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Risk Management ServicesC R A F T B R E W E R Y / D I S T I L L E R Y R E C A L L P O L I C Y

TABLE OF CONTENTS

DEFINITIONS ................................................................................................................................................. 3

RECALL PROCEDURE ....................................................................................................................................... 3Roles and Responsibilities ....................................................................................................................................................4 Recall Actions & Documentation ............................................................................................................................................5 Decision to Recall ..............................................................................................................................................................5 Evaluation of the Complaint or Condition ................................................................................................................................5Scope of Recall and Traceability ...........................................................................................................................................5 Identification of Implicated Products .......................................................................................................................................6 Notification of Affected Parties .............................................................................................................................................6 Regaining Control of Affected Stock .......................................................................................................................................6

EFFECTIVENESS OF THE RECALL ...................................................................................................................... 7

TESTING & REVIEWING THE PRODUCT RECALL PLAN ........................................................................................ 7

APPENDIX A .................................................................................................................................................. 7FDA Information .............................................................................................................................................. 7

APPENDIX B ................................................................................................................................................ 13Model Recall Letter (generic, all centers) ...............................................................................................................................13Model Recall Return Response Form (used with a Distributor) .....................................................................................................14Distributor Product Recall program - affidavit of product destruction .............................................................................................15Sample Press Release .......................................................................................................................................................15

APPENDIX C ................................................................................................................................................ 16Assigned Responsibilities ...................................................................................................................................................16Assignment .....................................................................................................................................................................16Evaluation ......................................................................................................................................................................16Identification ...................................................................................................................................................................16Notification ....................................................................................................................................................................16Removal .........................................................................................................................................................................16

APPENDIX D – ADDITIONAL RESOURCES ........................................................................................................ 17

CRAFT BREWERY / DISTILLERY RECALL POLICY

Risk Management Services

In the event that a food/beverage safety issue arises with our products, Craft Brewery/Distillery will protect public health by facilitating the efficient, rapid identification and removal of unsafe beverages from the distribution chain and by informing consumers (if necessary) of the presence of a potentially hazardous beverage in the market.

This policy will stay in place and will be periodically tested and updated to ensure that it is comprehensive and fit for the purpose of removing an unsafe product from the marketplace and distribution chain. Key individuals involved in the Recall process should periodically review this procedure and maintain familiarity with the overall program and their specific duties.

Definitions Certain terms used throughout this plan or referred to are listed below to ensure all parties involved understand the correct meanings.

• Class I Recall – A situation in which there is a reasonable probability that the use of, or exposure to, a defective product will cause serious adverse health consequences or death

• Class II Recall – A situation in which use of, or exposure to, a defective product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

• Class III Recall – A situation in which use of, or exposure to, a defective product is not likely to cause adverse health consequences. • Depth of Recall – The level of product distribution for the recall (consumer, retail, institutional, wholesale)• Distribution List – A product specific distribution list that identifies accounts that received the recalled product. Requested information

includes type of business, account name, addresses, and contact information• Market Withdrawal – A firm’s removal or correction of a distributed product that involves a minor violation that would not

be subject to legal action by the regulatory agency or that involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

• Press Release – A notice that alerts the public (including regulators, retailers, consignees, other distributors, processors, and consumers) that a product presents a serious hazard to health. Not all recalls require a press release; the regulatory agency will advise the firm when a press release is necessary

• Recall Committee – The group comprised of key staff with the expertise, authority, and responsibility to manage the recall• Recall Strategy – A planned specific course of action to be taken in conducting a specific recall, which addresses the depth and

scope of recall, need for public warnings, and extent of effectiveness checks for the recall• Scope of Recall – Defines the amount and kind of product in question• Stock Recovery – A firm’s removal or correction of a product that has not been marketed or that has not left the direct control of the

firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use

Recall Procedure IntroductionThis procedure states the actions Craft Brewery/Distillery Company will take to effectively manage the recall of a beverage that has been determined to be unsafe or unsuitable. The plan will be activated whenever a potential recall requirement arises and includes the following elements:

1. Recall committee member identification2. Recall responsibility assignments3. Key personnel and external contact information 4. Recall procedures 5. Communication templates

There are two levels of product recall. These are as follows:

Recall (also known as a consumer level recall):This is a removal of an unsafe beverage from the distribution chain and extends to products sold to consumers and therefore involves communication with consumers.

Withdrawal (also known as a trade level recall):This is the removal of the product from the distribution chain for reasons other than health/contamination concerns. (See the following explanation)

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CRAFT BREWERY / DISTILLERY RECALL POLICY - continued

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A product recall removes products from distribution, sale, or consumption that present a significant health or safety threat because of a product defect or contamination. This can either be at the trade or consumer level. Recalling food products can happen because of a report or complaint from manufacturers, wholesalers, retailers, government, or consumers. It can also occur after the business itself has run internal tests and audits. A product withdrawal, on the other hand, is where a product is removed from the supply chain — but not for health or safety reasons. For example, if something has been labelled with the wrong weight, the manufacturer may want to withdraw it. But if that same product was labelled with the wrong ingredients and allergens, this would then be a recall. Manufacturers sometimes also withdraw products as a precaution, waiting further investigation of a potential public health risk. If that risk is established, the food must be recalled.

Roles and Responsibilities:Recall CoordinatorThe recall coordinator has been given authority by management of the (Craft Brewery/Distillery) Company to execute the activities of the recall. Responsibilities of the recall coordinator include, but are not limited to:

• Assure the documentation of all recall decisions and actions in a master recall file• Initiate the formation of the recall committee• Activate various components within the company for priority assistance• Make recall decisions on behalf of (Craft Brewery/Distillery)• Manage and coordinate the implementation of the company’s product recall• Keep management informed

The recall coordinator for the site is (insert name), who has been given authority from management to make recall decisions on behalf of Craft Brewery/Distillery.

The Recall CommitteeThe recall coordinator (insert name) will initiate the formation of a committee and will coordinate actions with the FDA and our marketing and distribution agents.

The recall committee is responsible for the management of all recall activities and to adhere to this procedure. Duties of the recall committee are to:

• Assess the overall problem• Notify the relevant regulatory authority• Evaluate the hazard in the food and the extent of contamination• Determine a strategy to be followed• Make decisions about product still in manufacture or in storage• Decide who makes any press statements• Notify insurers (must be done immediately because recalls are covered by our insurance)• Notify legal counsel (insurance requires involvement of lawyers due to potential claims)

They will provide reports as required by the coordinator on their investigation.

(Craft Brewery/Distillery) will provide specific assignments and responsibilities for each committee member as it relates to their area of responsibility listed below. These should be documented as part of the recall program here.

Recall Committee AssignmentsCommittee members will include personnel from across our company. The committee will represent a cross section of management, manufacturing, marketing, and distribution representatives from the following areas:

• Production• Quality• Purchasing• Marketing• Sales• Legal services• Distribution & supply• Consumer affairs/public relations• Accounting• Management/administration

Recall CommitteeMembers’ names can be entered here with expansion of format to accommodate all members. This list should be dated and reviewed every six months for accuracy. (Individuals listed on this form presently are for example purposes only.)


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Contact Title Home Phone Cell Phone

President

Director of Operations

Recall Coordinator

Recall Coordinator (Alternate)

Risk Assessment

Risk Assessment (Alternate)

Plant Manager

Asst. Plant Manager (Alternate)

Shipping

Shipping (Alternate)

Recall Actions & DocumentationIt is our responsibility to manage the recall by clarifying the beverage safety issue and the exposure (who and where risk exists), and to provide details on distribution and the method of recall.

The government agency related to our product line involved in recalls is the U.S. FDA. The FDA should be notified as soon as a recall is likely.

Decision to RecallThe decision on whether to recall or withdraw a product(s) will be based on the identification of a hazard that makes a beverage unsafe and its likelihood of affecting public health. This will be determined by careful, considered risk assessment. The recall committee will conduct a risk analysis to determine the nature of the defect or problem and to what extent it may affect the customer.

Recall Procedures• Evaluation of the Complaint or Condition • Scope of Recall and Traceability• Identification of Implicated Products • Notification of Affected Parties • Regaining Control of Affected Products

Evaluation of the Complaint or ConditionComplaint receipt, processing, and evaluation are the first steps in the recall process. The steps involved in the evaluation process are:

• Receive the complaint – A file should be maintained containing any product complaints the company receives. Information that should be maintained in the product complaint file includes:

o Complainant contact information o Reported problem with the product o Product Identification o Product Storage o Product purchase date and location o Illness and/or injury details

• Provide the complaint to knowledgeable staff for initial evaluation. If an initial assessment indicates a recall may be necessary, the Recall Coordinator assembles the Recall Committee for a full evaluation

• Determine the hazard and evaluate the safety concerns with the product• Determine the product removal strategy appropriate to the threat and location in commerce• Contact the appropriate regulatory authorities• Alert legal counsel, insurance company, etc. as appropriate• Maintain a log of the events of the recall including information such as dates, actions, communications, and decisions

Scope of Recall and TraceabilityThe scope of a recall is a very important part of the process; it ultimately ensures the effective identification of all affected product(s), ingredient(s), and locations. Ingredients from suppliers must be traceable through production. Any foreign ingredients should be identified by an asterisk or other reliable method. The system in place at (Craft Brewery/Distillery) for tracking production and related customer sales involves the use of (insert applicable system here/below):

• Production date assigned to customer codes?• Batch codes assigned to shipment orders?• Lot #’s assigned to customer orders?


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Identification of Implicated ProductsIt is important to identify all products and quantities of products implicated in the recall. In addition, determination should be made if any other codes, brands, or sizes of product handled by the company are affected.

A distribution list should be prepared as part of the identification process. The distribution list should at minimum identify:• Account name (consignees) that received the recalled product(s) • Account addresses • Contact names • Contact telephone numbers • Type of account (e.g., manufacturer, distributor, retailer)

Additional information relating to product information may include:• Amount of product received /shipped • Product ship date(s) • Amount of product returned • Amount of product consumed

Notification of Affected PartiesNotifications during a recall must be done in a timely manner and should include the appropriate regulatory agencies, the product distribution chain, and consumers when necessary. Recall notices are typically used to notify regulatory agencies and those businesses in the distribution chain. Press releases are generally oriented to consumers, but may be used to notify any affected party.

• Regulatory agencies should be notified at the earliest opportunity after the decision has been made to conduct a recall. Regulatory guidance may be found at: www.fda.gov/safety/recalls/industryguidance/ucm129259.htm

• Subsequent to the initial notification, the regulatory authority should be updated throughout the recall process• Distribution Chain contacts will be notified by appropriate means (telephone, fax, email, letter, etc.). It is recommended that a written

recall notice be provided to all consignees. The Recall Notice must include all relevant recall information (see Appendix A)• Confirm receipt of the Notice of Recall with all accounts. A record of all account communications should be maintained• Consumers should be notified by the most effective method available. If appropriate a press release can be used to notify consumers

Considerations for preparing a press release include: o Issuance of a press release should be the highest priority and should be issued promptly o The local FDA District Recall Coordinator should be consulted before issuance of a press release whenever possible o All relevant information should be included in the press release (see sample templates in Appendix A)

Contact listThe contact list must contain the contact details for the following:

• The product recall committee and senior management and key company personnel• Suppliers of all ingredients• Distribution company and business customers• Sources of technical advice and support including laboratory facilities• Regulatory authorities

The contact list for all Craft Brewery/Distillery personnel related to this recall program is filed in the (insert list or location here).

Federal Agency responsible for food & beverage recalls:U.S. Department of Health and Human ServicesFood and Drug AdministrationOffice of Regulatory AffairsOffice of EnforcementDivision of Compliance Management and Operations10903 New Hampshire AvenueWO32 - RM4367Silver Spring, MD 20993(301) 796-8200

www.fda.gov/safety/recalls/industryguidance/ucm129259.htm

Regaining Control of Affected StockIf affected stock is directed to be returned to us, then the recovered product(s) will be stored in an area that is separated from any other beverage products and will be clearly marked as “RECALLED PRODUCT” until the final disposition can be determined. Accurate records will be kept of the amounts recovered and the codes of the product(s). All quantities and identification codes shall be documented to assist in the reconciliation of product amounts.


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If the recovered product(s) is unfit for human consumption, it may be destroyed or denatured under the supervision of the company management and /or the regulatory authority where legally required. If the product is to be disposed of in bulk down city sewage systems, the EPA or municipality should be contacted to ensure no environmental hazard is created.

If the product is to be destroyed by the Distributor, all affected “Lots” must be verified before destruction and return documentation verified for this action.

Product DispositionThe final disposition of the recovered product must be determined. The final disposition must be reviewed and approved by the regulatory agency. Options include:

• Redirection – Products may be redirected for uses other than human consumption• Destruction – Products determined to be unsafe for human consumption may be destroyed or denatured, and disposed by

appropriate means • Recondition – Products may be reworked to remove the safety risk. For example, would be relabeling a product to declare an

allergen originally omitted from the label.

All quantities, identification codes, and disposition shall be documented.

Effectiveness of the RecallTo be effective, the product recall notification must reach as far as the product has been distributed. The effectiveness of the product recall is assessed on the basis of the amount of product returned as a proportion of the amount of product that left while taking into account time in the distribution chain and the retail turnover of the product.

Progress of the product recall must be reviewed so that its success can be monitored. If it is decided that there is now little risk to the public, the product recall can be judged to have been a success and brought to an end. However, if there have been few returns and little response to a high risk problem, the product recall procedure must be reassessed. The product recall may have to be repeated using different methods to reach the consumer.

Testing & Reviewing the Product Recall PlanThe recall committee will review this procedure every twelve months, and the contact list will be amended as required. The procedure will also be reviewed after any recall.

A mock recall exercise will be conducted annually unless a real recall occurs. The effectiveness of this exercise will be evaluated, and records of these mock recalls will be documented and filed in the (insert file location here). Once the mock recall is completed, a review must be carried out with the relevant recall committee members to correct and improve the process where necessary.

APPENDIX AFDA Information

This guidance document is intended to provide guidance and instructions to FDA regulated industry for obtaining information to help fulfill the Agency’s plans regarding product recalls. It represents the agency’s current thinking on product recalls. This guidance does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. To discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. This guidance is available electronically to the public.

Date Issued: 11/3/03

INTRODUCTIONThis guidance is intended to assist those members of industry regulated by the Food and Drug Administration (FDA) in handling all aspects of a product recall, including all corrections and removals. The guidance includes a checklist of documentation and information that FDA utilizes to evaluate, classify, monitor, and audit product recalls. Various statutory provisions and regulations, described below, authorize FDA to require recalls of certain products in particular circumstances. Additionally, Subpart C of Part 7 of FDA regulations (21 CFR 7.40-59) provides general guidance for the voluntary recall of products, including those recalls initiated by a firm on its own and at FDA’s request. This guidance provides more specific recommendations and applies to both mandatory and voluntary recalls of all FDA-regulated products (i.e. food, including animal feed; drugs, including animal drugs; medical and radiological devices; cosmetics; human biological products including blood; and human tissue.)


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This is a level 2 guidance document published for immediate implementation in accordance with FDA’s good guidance practices (21 CFR 10.115). This guidance sets forth the agency’s existing practices in the handling of recalls. Interested parties may submit comments on this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.Guidance’s describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance’s means that something is suggested or recommended, but not required.

Certain statutory provisions authorize mandatory recalls of infant formula (21 USC § 350a(e)-(g)), medical devices (21 USC § 360h(e)), and human biological products (42 USC § 262). Additionally, FDA regulations set forth specific requirements for mandatory infant formula recalls (Subpart E of 21 CFR Part 107), medical device corrections and removals (21 CFR Part 806), and mandatory human tissue recalls (Subpart D of 21 CFR Part 1270). In addition to the requirements in these statutory provisions and regulations, the guidance’s specific recommendations would also apply to these types of recalls. In the context of a mandatory recall, those conditions in the guidance that are already set forth in a statute and/or regulation would be requirements, rather than recommendations, under the applicable statute and/or regulation.

FDA believes the cooperation of manufacturers and distributors in expediting recall activities is vital because of the determination that a distributed product is potentially hazardous to the public or animals and/or is in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Recalling firms are urged to notify the local FDA District Recall Coordinator as soon as a decision is made that a recall is appropriate and prior to the issuance of press or written notification to customers. For your local recall coordinator, please check the following website: http://www.fda.gov/Safety/Recall/IndustryGuidance/ucm129334.htm

It is recommended that you submit the information outlined in this guidance to your local FDA District Recall Coordinator as soon as possible after the decision to recall is made and the coordinator notified. It is recommended that you do not wait to submit this information until ALL applicable information is prepared and assembled prior to FDA notification. This “early” notification will allow FDA the opportunity to review and comment on your written notification and to offer guidance and assistance in your recall process.

A. Recall Submission to FDAWe recommend that you include the following information in your recall submission:

1. PRODUCT INFORMATIONa. Product name (include brand name and generic name)b. Model, catalogue, or product order number(s)c. Description of the product

i. Include if product is powder, liquid, tablet, capsule, etc.ii. Include the intended use or indicationsiii. If the product is perishable, include the expected shelf lifeiv. Include type of packaging (i.e. box, flexible plastic, glass)

d. TWO COMPLETE SETS OF ALL labeling to your local FDA District Recall Coordinator. Include:i. Product labeling (including ALL private labels)ii. Individual package labeliii. Case label (photocopy acceptable)iv. Package insertsv. Directions for usevi. Promotional material (if applicable)

2. CODES (Production Identification Numbers):a. Lot/Unit Numbers

(NOTE: If “all lots” are involved or the product is not coded, explain how non-recalled, or reintroduced product may be distinguished from product subject to recall. Provide an explanation of your lot number coding system.)

b. Expiration date(s) or Use by date(s) or Expected shelf life of productc. Serial numbers (medical devices)d. UPC codes


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3. RECALLING FIRMa. Firm name, address, city, state, zip codeb. Identify firm type (i.e. manufacturer, importer, broker, re-packer, own-label distributor)c. Contacts for Recalling Firm

i. Name/title/phone/fax number/e-mail address for RECALL contactii. Name/title/address/phone/fax number of the most responsible individual for the recalling firmiii. Name/title/phone/fax number/e-mail address for public contact

4. MANUFACTURER:a. Firm name, address, city, state, zip codeb. FDA registration number, if applicable

5. IDENTIFY FIRM RESPONSIBLE FOR THE VIOLATION/PROBLEM: a. Firm name, address, city, state, zip code

6. REASON FOR THE RECALL: a. Explain in detail how product is defective and/or violativeb. Explain how the defect affects the performance and safety of the product. (Also see #5, Health Hazard Assessment)c. If the recall is due to the presence of a foreign object, describe the foreign object’s size, composition, hardness, and

sharpnessd. If the recall is due to the presence of a contaminant (cleaning fluid, machine oil, paint vapors), explain level of contaminant

in the product. Provide labeling, a list of ingredients and the Material Safety Data Sheet for the contaminante. If the recall is due to failure of the product to meet product specifications, provide the specifications and report all test

results. Provide copies of any sample analysisf. If the recall is due to a label/ingredient issue, provide and identify the correct and incorrect label(s), description(s), and

formulation(s)g. Please explain how the problem occurred and the date(s) it occurredh. Explain how the problem was discovered and the date discoveredi. Please explain if the problem/defect affects ALL units subject to recall, or just a portion of the units in the lots subject to

recallj. Explain why this problem affects only those products/lots subject to recallk. Provide detailed information on complaints associated with the product/problem:

i. Date of complaintii. Description of complaint - include details of any injury or illnessiii. Lot Number/Serial Number involved

7. HEALTH HAZARD ASSESSMENT: a. Please provide your assessment of the health risk associated with the deficiency.

NOTE: A recall decision does not depend solely on the health risk of the product. Defective products and misbranded products where no health hazard exists are still in violation of the law and should be recalled

8. VOLUME OF RECALLED PRODUCT: a. Total quantity producedb. Date(s) producedc. Quantity distributedd. Date(s) distributede. Quantity on HOLD by Recalling firm and its distribution centers.f. Indicate how the product is being quarantinedg. Estimate amount remaining in marketplace

i. Distributor levelii. Retail leveliii. Pharmacy or veterinary level (drugs)iv. User level (i.e. Medical Devices)

h. Provide the status/disposition of marketed product, if known, (e.g. used, transfused, implanted, used in further manufacturing, or destroyed)


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9. DISTRIBUTION PATTERN: a. Number of DIRECT accounts (customers you sell directly to) by type, for example:

i. Wholesalers/distributorsii. Re-packersiii. Manufacturersiv. Retail/pharmacy/veterinarianv. Users (medical devices - hospitals, clinics, laboratories)vi. Consumers (internet or catalog sales)vii. Federal government consigneesviii. Foreign consignees (specify whether they are wholesale distributors, retailers or users)

b. Geographic areas of distribution, including foreign countries

10. PROVIDE A CONSIGNEE LIST (names/address/city/state/contact name/phone number) to the local District Recall Coordinator. Be sure to include any foreign (including Canadian) customers and federal government consignees (USDA agencies, Veterans Affairs, Department of Defense). a. Indicate what the consignee list represents (i.e. all customers who were shipped recalled product; all customers who

were sold recalled product; all customers who may have been shipped or sold recalled product because it was sold to them within the applicable time period.)

b. Was product sold under a government contract? If yes, provide contract number, contract date, and implementation date. If no, indicate so

c. Was product sold to any federal, state, or local agency involved in the school lunch program? If yes, list the consignees and provide quantity and sale and shipment date

d. In addition, it is recommended that you notify both “ship to” and “bill to” customers of the recall so thati. “Ship to” customers retrieve the product from their locationii. “Bill to” customers, if responsible, initiate the subrecall

11. RECALL STRATEGYa. Indicate the level in the distribution chain to which you are extending the recall (i.e. wholesale/retail/pharmacy/

medical user). If your recall only extends to the wholesale/distributor level, we recommend that you explain your rationale for not recalling to retail/pharmacy level

b. Indicate the method of notification (i.e. mail, phone, facsimile, e-mail). It is advisable to include a written notification so customers will have a record of the recall and your instructions

c. Indicate how letters will be sent to customers (e.g. overnight mail, first class mail, certified mail, facsimile).d. If initial notification is by phone, provide a copy of the phone script to FDAe. If you have a website, you should consider posting the recall notification on the website as an additional method of

recall notification. (Note: This is not recommended as a sole means of customer notification.)f. Report on what you have instructed customers to do with the recalled productg. It is helpful for recalling firms to know the name and title of the Recall Contact for each of its consignees. Addressing a

recall notification letter to a Recall Contact will expedite the recall process and reduce the potential for the notification letter to get misdirected.

h. If product is to be returned, explain the mechanics of the processi. Explain if this recall will create a market shortage that will have an impact on the consumerj. Report on recall effectiveness check strategy. Include your actions for non-responders. See: http://www.accessdata.

fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfmk. Determine and provide your course of action for out-of-business distributorsl. Provide a proposed method of destruction, if applicablem. If the product is to be “reconditioned,” explain how and where the reconditioning will take place. Please provide details

of the reconditioning plan to your local FDA District Recall Coordinator before implementation. All reconditioning must be conducted under any applicable Current Good Manufacturing Processes

n. Describe how reconditioned product will be identified so it is not confused with recalled (pre-reconditioned) product.o. In addition, we recommend that:

i. You contact your local FDA District Recall Coordinator prior to product destruction. FDA will review your proposed method of destruction and may choose to witness the destruction

ii. The recalling firm and customers keep adequate documentation of product destruction (and whether or not destruction was witnessed by an FDA investigator)


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iii. Field corrections, (i.e. product relabeling), be performed by recalling firm representatives, or under their supervision and control. It is not recommended that a disinterested party such as a wholesaler or retailer be responsible for field corrections. For Drug Recalls: Misbranded drugs for re-labeling should be returned to the recalling firm

iv. You contact your local District Recall Coordinator prior to the release of reconditioned goods

B. Publication Notification

1. PRESS RELEASE: In a situation where the product may pose a significant health hazard and the recalled product is in the hands of consumers, a press release is usually appropriate. Issuance of a press release should be the highest priority and it should be issued promptly. Unique situations will be handled on a case-by-case basisa. You should consult with your local District Recall Coordinator before issuance of a press release whenever possible. A

joint press release may benefit the firm and FDA by alerting the public to a serious health hazard or situations deemed to be in the public interest. Model Press Release Guidance is available on the FDA website at: http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm NOTE: For those recalls where the FDA believes a press release is warranted, the Agency will issue a press release if the firm has failed to do so, or if the firm-initiated press release is not adequate

2. GUIDANCE FOR WRITTEN RECALL NOTIFICATION LETTERS: Recall Notifications should be flagged in large bold print “URGENT: [insert “FOOD”, “DRUG”, “MEDICAL DEVICE”, etc.] RECALL or CORRECTION.” Envelopes should be similarly flagged. The FDA recommends that you include the following information in a recall notification:a. PRODUCT IDENTIFICATION

i. Include an accurate and complete description of the product and any codes used to identify the product, e.g. lot/unit numbers, expiration date, serial numbers, catalog numbers, model numbers, and UPC codes

ii. Consider including a copy of the product label with the recall notification. This could be helpful for wholesalers and retailers in identifying and removing the recalled product

b. DESCRIPTION OF THE PROBLEM: i. Identify the problem and any potential health hazard(s) associated with it

c. DEPTH OF THE RECALL: i. The recall notification should clearly identify the depth to which the recall is to extend (e.g. wholesale, retail, or user

level). If the recall is to the retail level, a statement should read “This recall is to the retail level”ii. If the product could have been further distributed by your customers, then you should include instructions to

subrecall. Subrecall instruction should also include the depth of the recall, e.g. “If you have further distributed this product, you should notify your customers to the retail level”1. If your customers are instructed to conduct subrecalls, it is advisable to provide them with the date range that

the recalled product was distributed. Wholesalers/distributors may need this information in order to identify customers they shipped/sold recalled product to

2. You should consider providing a subrecall letter with your notification package for your customers to further notify their sub accounts. You are then assuring that the information to sub accounts is accurate and complete.

d. INSTRUCTIONS TO CUSTOMERS: i. Your recall INSTRUCTIONS should be clear. For example: ii. Remove product from saleiii. Cease distributioniv. Subrecall (if appropriate)v. Return productvi. Explain procedure for product correctionvii. Include a RETURN RESPONSE card/form. This return response card/form should include all instructions from your

recall letter. Your customers should be required to indicate that they followed every instruction.viii. Provide examples of ALL recall communications (include letters, attachments, envelope) to your local District Recall

Coordinator.ix. IMPORTANT: All customers in the distribution chain should be NOTIFIED of the recall, preferably in writing. Here

are some examples of why this is important:1. In the case of a human drug recall, the FDA does not believe it is appropriate for a salesman to visit a doctor’s

office and remove product without notifying the physician or responsible staff. Physicians may be treating patients that may suffer or have suffered some adverse effect from the drug subject to recall. With knowledge of the recall and the reason for the recall, the physician can better evaluate a patient’s condition and provide appropriate patient care.


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2. In the case of products sold at retail stores, the FDA does not believe it is appropriate for a salesman or broker representatives to remove product from retail shelves without informing store management of the recall. Failure to inform store management of the recall could result in product that is in storage, in transit to the store, or returned by customers, being offered for sale. The salesmen or broker representatives may not have knowledge or access to the recalled products stored in back rooms. Recalled products that are in-transit to the store would then be sold to customers. Recalled products returned by customers may be placed back on store shelves.

C. Evaluation of the Recall

1. EFFECTIVENESS OF THE RECALL: It is the recalling firm’s responsibility to assure that the recall is effective. Therefore, we recommend that you consider effectiveness checks for every recall. The purpose of an effectiveness check is to verify your recall notification letter was received by the customer, that the customer read and understood the letter and followed the recall instructions. The effectiveness check should also verify your recall reached the appropriate level in the distribution chain.

2. RECALL STATUS REPORTS: You will be asked to provide Recall Status Reports after initiating a recall (usually on a monthly basis but more frequently when indicated) to your local District Recall Coordinator. The reports requested will usually include the following informationa. Dates customers notifiedb. Number of customers notifiedc. Number of customers respondingd. Quantity of RECALLED product returned or accounted fore. Details of your recall effectiveness checks

3. ROOT CAUSE OF THE PROBLEM THAT RESULTED IN THE RECALL: We recommend that you provide this information to your local District Recall Coordinator once the root cause has been established. It is important to establish the root cause of the problem so that appropriate preventative measures can be taken

4. CORRECTIVE ACTIONS TO PREVENT FUTURE OCCURRENCES OF THE PROBLEM: We recommend that you explain the corrective actions planned or underway that will prevent a similar problem from occurring. We further recommend that you provide this information to your local District Recall Coordinator when it has been established

5. TERMINATION OF THE RECALL: We recommend that you evaluate your recall for termination when all possible customer responses have been received and it is reasonable to assume that the recalled product has been recovered, corrected, reconditioned, or destroyed. A final status report and documentation of recalled product disposition should be provided to your local District Recall Coordinator before the FDA will consider formal termination of the recall action. See: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=7.55 Note: Upon receipt of necessary termination information, the district’s recall coordinator will prepare a recall termination document for Center and/or district management concurrence. When concurrence is obtained, the district office will notify the recalling firm that FDA considers the recall terminated

Additional Guidance and/or Requirements:21CFR Part 7, Subparts A and C - Recalls - General guidelines

FDA District Recall CoordinatorsA current list of FDA recall coordinators can be found on FDA’s website at:http://www.fda.gov/Safety/Recall/IndustryGuidance/ucm129334.htm


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APPENDIX BModel Recall Letter (generic, all centers)

<Company Name - Letterhead>

URGENT: < Insert FOOD, DRUG, MEDICAL DEVICE, BIOLOGIC, COSMETIC, etc.> RECALL <DATE> <Contact name or Dept.> <Firm Name> <Address> <City/state/zip>

Dear < >:

This is to inform you of a product recall involving:

<Insert: PRODUCT NAME, BRAND NAME, DESCRIPTION, UPC CODES, LOT NUMBERS>

See enclosed product label <for ease in identifying the product at retail/user level>.

This recall has been initiated due to <problem>. Use of <or consumption of> this product may <include any potential health hazard>.

We began shipping this product on <date> (or) This product was shipped to you on <date>. (If possible, provide consignee with shipping dates and quantities shipped.)

Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter, or <Enclosed is a letter you should use in notifying your customers>.

[Your notification must include instructions on what customers should do with the recalled product.]

This recall should be carried out to the <wholesale>, <retail>, <consumer>, <user> level.

Your assistance is appreciated and necessary to prevent <i.e. consumer illness or patient harm>.

Please complete and return the enclosed response form as soon as possible.

If you have any questions, call <name and telephone number>.

This recall is being made with the knowledge of the Food and Drug Administration.

Regulatory Procedures Manual March 2009 Chapter 7 Recall Procedures

7-59Name:Title:Enclosure(s):


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Model Recall Return Response Form (used with a Distributor)

<Company Name - Letterhead><Insert Product><Insert Lot Numbers>

Please check ALL appropriate boxes. � I have read and understand the recall instructions provided in the <date> letter. � I have checked my stock and have quarantined inventory consisting of _____ <units or cases>.

Indicate disposition of recalled product: � Returned (specify quantity, date, and method)/held for return; � Destroyed (specify quantity, date, and method); � Relabeled (specify quantity and date); � Quarantined pending correction (specify quantity); � Transfused – Blood or blood products (specify date and quantity); � Implanted (specify date and quantity)

� I have identified and notified my customers that were shipped or may have been shipped this product by (specify date and method of notification); <or>

� Attached is a list of customers who received/may have received this product. Please notify my customers.

Any adverse events associated with recalled product? o Yes or o NoIf yes, please explain: _____________________________________________________

Name: ____________________________________Title: ____________________________________Tel. number: ( ) ______________________________Regulatory Procedures Manual March 2009 Chapter 7 Recall Procedures

7-61Firm name: __________________________________________address: __________________________________________City/State: __________________________________________

PLEASE FAX COMPLETED RESPONSE FORM TO Tel. # < >, ATTN: < >

OR MAIL TO: FIRM NAME AND ADDRESS

NOTE: This MODEL is intended to serve as guidance for recalling firms. It may not conform to your firm’s recall strategy. Please make any appropriate modifications to the response form. IT IS ADVISABLE TO SUBMIT THE PROPOSED RECALL LETTER AND RESPONSE FORM TO YOUR LOCAL FDA RECALL COORDINATOR FOR REVIEW, PRIOR TO ISSUANCE.


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Distributor Product Recall program - affidavit of product destruction

<Company Name - Letterhead>

You have been requested by <Company name> to destroy product described below because it did not meet our strict safety and/or quality standards.

Product Description with Code Date: _________________________________

Please complete form and return to:<name><fax>

Store/Warehouse: Name:

Address:

Amount of Product in Stock:

Amount of Product Destroyed:

Method Used to Destroy Product:

Your Name (print)

Your Signature / date

Your Title:

Witness (print):

Witness Signature / date:

Sample Press Release

Company XYZ:Address:Date:For Immediate release:

The Craft Brewery/Distillery Company of _________________, announced today that as a precaution to the public, it is recalling its ______________________ beer which is processed at its __________ plant because of (contaminant ? flavor alteration ? ) in part of the day’s production. No injury/illness has been reported. The company’s quality assurance personnel found the defect in the ______bearing the code number _______and distributed in Metropolitan Hollywood, CA. ? . No other code dates of this product were affected.The company’s findings and corrective actions were reported to the Food & Drug Administration and to prevent future occurrence, Craft Brewery has instituted improved quality control programs.

Please return this beer product to your local retailer for a full refund.

Any questions or concerns can be addressed by our representatives at: 1 800 xxx xxxx.

(Filled in by: Director of Operations / Recall Coordinator)


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APPENDIX CAssigned Responsibilities

Sample Assignments (may include, but not limited to the following)

Assignment

1. Management of the recall – (Insert Name, Title) is responsible for the coordination of all recall activities.

2. Assemble the Recall Committee – (Insert Name, Title) is responsible for communicating the decision to recall to the members of the Recall Committee and that each member knows their responsibilities.

Evaluation

1. Management approval of the recall – (Insert Name, Title) is responsible to decide if the recall should go forward.

Identification

1. Create a product recall log – (Insert Name, Title) is responsible to create and maintain a product recall log to document all events, when they occur and the company’s response to each.

2. Identify all products to be recalled – (Insert Name, Title) is responsible for identifying all products which need to be recalled.

Notification

1. Notify the appropriate regulatory authority – (Insert Name, Title) is responsible for notifying the appropriate regulatory authority (use the contact information in the Recall Plan). Contacts shall only be made through the designated committee member. Recommended information to be submitted can be found in the FDA guidance document at: http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm

2. Prepare the press release (if required) – (Insert Name, Title) is responsible for the recall press release if the decision to prepare a press release is made. Considerations for preparing a press release include:a. Issuance of a press release should be the highest priority and it should be issued promptlyb. Consult with your local District Recall Coordinator before issuance of a press release whenever possiblec. If the company decides to prepare the press release, include all relevant information (see sample templates in Appendix B)

3. Prepare the distribution list – (Insert Name, Title) is responsible for preparing the recalled product distribution list. The FDB distribution list template requests account type, name, address, phone number, and contact name

4. Prepare the Notice of Recall – (Insert Name, Title) is responsible for preparing the written notice includes all recall relevant information (see FDA Guidance for Written Recall Notification Letters in Appendix)

5. Distribute the Notice of Recall – (Insert Name, Title) is responsible for distribution of the Notice of Recall to all accounts that received the recalled product. Responsibilities include: a. Confirm receipt of the Notice of Recall with all accountsb. Contact accounts that have not responded to the request for conformationc. Maintain records of the account communications

Removal

1. Detain and segregate all products to be recalled that are in your firm’s control – (Insert Name, Title) – is responsible to ensure that all products to be recalled in the firm’s control are not distributed (identify, detain, and segregate products on-site, in transit, off-site storage, and off–site distribution)

2. Control the recalled product(s) – (Insert Name, Title) is responsible to ensure that recalled products do not re-enter commerce. Responsibilities include:a. Quarantine and clearly identify recalled productsb. Reconcile quantities, identification codes, and monitor recalled productsc. Document the returned products

3. Decide what to do with the recalled product(s) – (Insert Name, Title) is responsible for determining the action to be taken on the recalled product (destruction, reworking, and redirection). Other related responsibilities include:a. Determine if the regulatory authority requires actions such as witnessing destruction of the recalled productb. Verify that the action taken has been effectivec. Document the action(s) taken


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4. Verify recall effectiveness – (Insert Name, Title) – is responsible for verifying the effectiveness of the recall. Responsibilities include:a. Verify that distribution of recalled products has ceasedb. Verify that all consignees at the recall depth specified by the recall strategy have received notification about the recall.c. Verify that consignees have taken appropriate action.d. Document all verifications.

APPENDIX D1. Termination of a recall – 21 CFR Sec. 7.55

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=7.55

2. Industry Guidance: Information on Recalls of FDA Regulated Products http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm

3. US Food and Drug Administration http://www.fda.gov/

4. USDA (FSIS) http://www.fsis.usda.gov/wps/portal/fsis/home

5. Center for Disease Control http://www.cdc.gov/

6. FDA District Recall Coordinators http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129334.htm

7. FDA Defect Levels Handbook http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitationtransportation/ucm056174.htm

IMPORTANT NOTICE - The information and suggestions presented by Philadelphia Indemnity Insurance Company in this Technical Bulletin are for your consideration in your loss prevention efforts. They are not intended to be complete or definitive in identifying all hazards associated with your business, preventing workplace accidents, or complying with any safety related, or other, laws or regulations. You are encouraged to alter them to fit the specific hazards of your business and to have your legal counsel review all of your plans and company policies.

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