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AIB International GMP Inspection Results Report

Consolidated Standards for Inspection: Prerequisite and Food Safety Programs

Contacts US Office:1213 Bakers Way PO Box 3999, Manhattan, KS 66502-3999(785) 537-4750 ● (800) 633-5137 ● Fax (785) 537-0106

UK Office:

PO Box 11, Leatherhead, Surrey, KT22 7YZ+44-1372-360553 ● Fax +44-1372-361869

Website http://www.aibonline.org

The AIB International Consolidated Standards for Inspection are statements that represent key requirements that a facility must meet in order to keep products manufactured, processed or handled in a facility wholesome and safe. The Standards reflect what an inspector would expect to see in a facility that maintains a food-safe processing environment.

This report details the findings from an AIB International inspection against the Consolidated Standards. The document contains the following sections:

Document Section DescriptionScore and Rating x Description of the facility

x Number of findings and related risksx Category scores and total scorex Rating

Participant Names Personnel from the facility who accompanied the inspector

Facility-Specific Questions Technical information about a facility. For example: bulk materials used, temperature control equipment used.

Location Matrices Two matrices which categorize findings by Category and Risk

Findings with Risk Descriptions and recommendations related to all findings

Additional Comments Comments made by the inspector that have no risk assessment

Standards without identified Risks or Findings Standards that are applicable to the inspected facility, but based on random review and observation samplings at the time of the inspection, the facility appears to be meeting re-quirements

Standards Not Applicable Standards that are not applicable to the inspected facility

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The official version of this report is a certified pdf issued by AIB International

Score and RatingInspection Information:Facility Name Supply Chain Solutions LLC Standard Used Prerequisite and Food Safety ProgramsFacility Address 2300 Sitler St Bld 687

Memphis, Tennessee 38114United States

Date(s) of Inspection 25-Jun-2013 Audit Type GMPInspection Type Scored

Products Produced Single Serve Food Co-Packer. Announcement Type AnnouncedAccount # 26779

Expected Scope Yes Reinspection NoVariations From Expec-ted Scope

Terminated No

Score

CategoryMinor Issues

Noted (180-195)

Improvement Needed (160-175)

Serious (140-155)

Unsatisfactory <= 135 Scores

Operational Methods and Personnel Practices 1 0 0 0 195Maintenance for Food Safety 1 2 0 0 170Cleaning Practices 0 0 0 0 200Integrated Pest Management 0 0 0 0 200Adequacy of Prerequisite and Food Safety Programs 2 2 0 0 170Total Score 935

Disclaimer: AIB International Inc. states that this report as dated and provided herein is to be construed as its findings and recommendations, category scores, total score, and rating. A passing score of 700 and above is not a certification of the facility, products, or programs. AIB International Inc. does not accept or assume responsibility for the Prerequisite and Food Safety Programs in effect with the customer named on the title page of this report (the customer). AIB International Inc. is only reporting the food safety conditions of the customer as of the date of this report and assumes no responsibility or liability as to whether the customer does or does not carry out the recommendations as contained in this report.

The official version of this report is the pdf issued by AIB InternationalSee Disclaimer on Score and Rating page

25-Jun-2013Announced

Supply Chain Solutions LLCMemphis, Tennessee United States

Participant NamesName Role Inspection Closing Meeting

Melvin Williams Line Lead Person Yes -

Mike Anderson Co-Pack Supervisor Yes Yes

Nancy Mendes H.R. Manager Yes Yes

Rob Taylor Outside PCO Yes -

Robert Keskey President Yes Yes

Melvin Pleasant Auditor Yes Yes

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Facility-Specific Questions# Question Comments

1.11 Does the facility use processing aids? No

1.11.a State the processing aid(s) used. N/A

1.11.b Are processing aids segregated from non-food materials? N/A

1.11.c Is food approval documentation provided? N/A

1.13 Does the facility use bulk dry materials? No

1.13.a State the bulk dry materials received. N/A

1.13.b Provide the screen size of the sifter. N/A

1.13.c State the frequency of screen and tailings checks. N/A

1.14 Does the facility use bulk liquid materials? No

1.14.a State the bulk liquid materials received. N/A

1.14.b State the locations of the strainers. N/A

1.14.c State the frequency of strainer inspections and if they are documented. N/A

1.15 Are foreign material control devices used? No

1.15.a List the devices used. N/A

1.15.b Are they present on all lines? N/A

1.15.c List the specific devices tested during the inspection. N/A

1.22 Does the site have temperature controlled areas such as coolers and freezers?

No

1.22.a State the temperatures noted at the time of the inspection. State if coolers are provided for quality or food safety purposes.

N/A

1.22.b State the method of temperature monitoring (manual or continuous). N/A

1.22.c State if an alarm system is present. N/A

1.25 Are cans, bottles, or other rigid packaging materials used at this facility? No

1.25.a What is the rigid packaging used (cans, bottles, drums)? N/A

1.25.b State how they are cleaned prior to filling (water, air rinse, etc.). N/A

1.25.c State if the systems were functional. N/A

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1.25.d State the maintenance frequency and if records were maintained for this equipment.

N/A

3.2 Does the facility use sanitizers on food contact surfaces? Yes

3.2.a Is sanitizing followed by a potable water rinse, where required by the sanitizer label?

Yes

3.2.b Is the sanitizer concentration verified? Titration System

3.2.c Are corrective actions documented when results are not in compliance with label directions?

Yes

3.7 Are CIP systems in use at the facility? No

3.7.a Are CIP records and recording charts maintained and current? N/A

3.7.b Are CIP records and recording charts reviewed to ensure the system is functioning as required?

N/A

4.3 Does the site manage their pest control program under other guidelines?

No

4.3.a State the guideline used. N/A

4.4 Are IPM services provided by a contractor? Yes

4.4.a State the name of the service provider. James Pest Management

4.5 Does the site require the use of IPM professionals (i.e., use of restricted use pesticides and/or state or national government regulations)? If yes, please state the reason.

Yes, State regulated

4.5.a State the expiration date of the PCO license(s). 12/31/14

4.5.b If licensing of the PCO is not required, were training records current? PCO Certification Required

4.5.c State the expiration date of the business license. 10/1/13

4.5.d State the expiration date of the certificate of insurance. 7/1/13

4.6 Were pesticides used at this facility? No

4.6.a List the names of the pesticides used, at a minimum, in the last 6 months or since the last AIB Inspection.

No pesticides used at this point

4.6.b Were current labels provided for the pesticides reviewed? Labels for pesticides approved to be used at facility on file

4.6.c Were current chemical safety data sheets provided for the pesticides reviewed?

Yes

5.2 Who was assigned responsibility for food safety at the facility? Co-Packing Supervisor

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5.2.a Does the facility have a current license to produce, manufacture, or store food products (local health department, state, or other agency)?

No

5.2.b Has the site implemented procedures to meet regulatory requirements (i.e., allergen labeling and control, Reportable Food Registry, Food Safety Modernization Act, etc.)?

Yes

5.10 Does the site have a documented Microbiological Control Program in place?

No

5.10.a State if testing is for sanitation, environmental, raw materials/finished product.

N/A

5.10.b State the microorganisms tested for. N/A

5.10.c If the facility is testing for pathogens, indicate if the testing is environmental only or if testing is done for raw materials, finished products, or food contact surfaces.

N/A

5.10.d If the site tests for pathogens, is the product or raw material placed on hold and not released until results indicating the food safety of the product have been obtained?

N/A

5.10.e Are documented disposition procedures and records in place for materials that test positive for pathogens?

N/A

5.10.f State if an in-house or outside lab is used. N/A

5.10.g If an outside lab is used, are they accredited? List the accreditation body.

N/A

5.11 Does this country have allergen regulations or does the site ship to countries with allergen regulations?

Yes

5.11.a State the allergens handled at this facility. N/A

5.16 Has the site been inspected by a regulatory agency in the past year? No

5.16.a State the name of the agency and the date of the inspection. N/A

5.16.b State if the facility addressed findings identified in the regulatory inspection.

N/A

5.22 List the materials for which specifications were reviewed. (Sample a minimum of one raw material, one food contact packaging material, and one finished product where possible.)

Finished Product Packaging Film

5.23 List the materials for which COA's or letters of guarantee were reviewed. (Sample a minimum of one raw material, one food contact packaging material, and one finished product where possible.)

Finished Product packaging Film

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5.24 Does this process have a kill step? No

5.24.a State the kill step. N/A

5.25 Is there a HACCP program in place? Yes

5.25.a List the CCP's. No CCP's

5.25.b State if the plan has been validated and who did the validation. Yes, Co-Packing Supervisor

5.25.c State the date of the most recent assessment. 4/29/13

5.25.d State the names of the products falling under regulatory HACCP produced or stored at this facility.

N/A

5.26 Does the site do specialized testing to meet country or regulatory requirements (i.e., pesticide residues, genetically modified organisms, heavy metals, radioactivity, allergens, mycotoxins, etc.)?

No

5.26.a State the specialized testing completed at this facility. N/A

5.29 How does the facility use potable water, ice, or steam for product contact?

No

5.29.a State the source of the potable water supply (well, city, etc.). City

5.29.b State the source of the records indicating potability. Memphis Light, Gas & Water Division

5.29.c Is ice made in-house or purchased? N/A

5.29.d List the source of testing records for ice and if they indicated that it was potable.

N/A

5.29.e Is food approval documentation provided for chemicals used for the generation of steam for food contact?

N/A

5.29.f List the source of testing records for steam used for product contact. N/A

5.29.g State if the back flow prevention devices are checked for function and provide the last date of testing.

Facility is located in an industrial park, main water line from city is the responsibility of the landlord. The facility had a back flow on its water line with documentation from certified plumber that back flow cannot be tested only replaced when it malfunctions.

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Findings by Location and Category

Locations

Operational Methods and

Personnel Practices

Maintenance for Food Safety

Cleaning Practices

Integrated Pest

Management

Adequacy of Prerequisite

and Food Safety

Programs

Totals by Location

Facility Overview 1 0 0 0 3 4

Outside Grounds and Roof 0 1 0 0 0 1

Packaging 0 1 0 0 0 1

Production 0 0 0 0 1 1

Shipping Area 0 2 0 0 0 2

Totals by Category 1 4 0 0 4 9

Findings by Location and Risk

Locations Minor Issues Noted Improvement Needed Serious Unsatisfactory Totals by

Location

Facility Overview 3 1 0 0 4

Outside Grounds and Roof 1 0 0 0 1

Packaging 0 1 0 0 1

Production 0 1 0 0 1

Shipping Area 0 2 0 0 2

Totals by Risk 4 5 0 0 9

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Findings with Risk.

# Risk Standard Standard # Requirement # Location. .

1 Improvement Needed (IN) Pest Prevention 2.11 2.11.1.2 Shipping AreaFinding: Gaps greater than Quarter in or 6 mm were noted in some areas. Gaps greater than Quarter in or 6 mm could allow pest

access into the facility. The large overhead door used to bring in equipment into the facility shipping dock area had a gap at the top of the door. The outside contractor did not put the brush seal at the top of the overhead door during the installation of brush seals on the door.

Recommendation: The top brush seal should be installed to prevent pest entry into the facility. Also the facility should initiate an inspection procedure for any work done by outside contractors to insure the work is completed to company specifications.

.

. 2 Improvement Needed (IN) Pest Prevention 2.11 2.11.1.2 Shipping Area

Finding: Gaps greater than Quarter in or 6 mm were noted in some areas. Gaps greater than Quarter in or 6 mm could allow pest access into the facility. The bottom concrete threshold of the overhead door used to bring in equipment next to the product shipping dock was not smooth preventing the bottom seal of the overhead door to fit securely, creating a gap between the seal and concrete threshold.

Recommendation: The concrete threshold on the floor base under the overhead door should be resurfaced and made smooth to allow the bottom seal of the door to securely fit eliminating the gaps at the bottom of the door.

.

. 3 Improvement Needed (IN) Equipment and Utensil Construction 2.15 2.15.1.1 Packaging

Finding: Not all equipment and utensils were designed and constructed of materials that were easily cleaned and maintained. The filler machine had a gap in the top film/filler cover which could allow overhead contamination.

Recommendation: The top Lexan cover over the film/filler needs to have the open section of the cover closed to prevent any potential contamination. The design of the cover should include a vent to allow the heat being generated in the filler/film area to escape to prevent condensation from building in the area which could effect the sealing process.

.

. 4 Improvement Needed (IN) Training and Education 5.5 5.5.1.3 Facility Overview

Finding: Defined requirements for ensuring of understanding and comprehension of training were not addressed for all of the Prerequisite and Food Safety Programs.

Recommendation: The facility should conduct exit criteria testing for all employees when they are hired to insure they have a good understanding of the product safety training materials.

.

. 5 Improvement Needed (IN) Preventive Maintenance Program 5.14 5.14.1.1 Production

Finding: A partially developed Preventive Maintenance Program and work order system was implemented for this facility. The equipment covering and building deficiencies noted during the audit to prevent contamination and pest control issues should be evaluated by the product safety committee.

Recommendation: The product safety committee and engineering department should talk to the filler manufacturer concerning the exposure on the filler machine which could allow contamination risks. Also the engineering department should talk to the building landlord about the needed repairs on the overhead door and building outside walls which could allow pest entry into the manufacturing building.

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.

. 6 Minor Issues Noted (MI) Finished Product Transportation 1.26 1.26.1.4 Facility Overview

Finding: The facility is transporting the finished product to the shipping trailer and must open the production/storage room to move the product to the shipping dock for load-out. No procedure was in place to insure the load-out door closed when production/storage room door opened.

Recommendation: The facility should write an SOP that states the shipping dock door cannot be open at the same time as the production/storage room door. The SOP should state that if one door is open the other door must be closed, so that pallets for shipment are moved to the shipping dock and staged when one of the doors is closed to prevent possible pest entry into the production/storage room.

.

. 7 Minor Issues Noted (MI) Walls 2.7 2.7.1.2 Outside Grounds and Roof

Finding: Holes or cracks were noted in wall surfaces. The shipping dock exterior wall did not have pest protection on the surface of the wall. The wall surface had holes in the surface of the wall, making the surface very rough and not smooth.

Recommendation: The shipping dock exterior wall should have a stainless steel flashing or epoxy paint installed on the surface of the wall to assist in the prevention of pest entry into the facility.

.

. 8 Minor Issues Noted (MI) Self-Inspections 5.6 5.6.2.3 Facility Overview

Finding: Down time was not included in the self-inspection program. The Facility is a new operation and should incorporate down time as a procure.

Recommendation: The facility is a new operation and has not begun formal operations, when operations begin down time assessments should be done of the facility and manufacturing equipment.

.

. 9 Minor Issues Noted (MI) Food Defense Program 5.17 5.17.1.3 Facility Overview

Finding: The Food Defense Plan did not include all elements as defined in this Standard.Recommendation: When the facility is fully staffed formal training should be given all employees regarding the food defense program and all

sections of the program..

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Additional Comments.

# Risk Standard Standard # Requirement # Location. .

1 Storage Conditions 1.4 1.4.1.4Finding: Packaging and finished products were inspected for signs of infestation on a regular basis.

.

. 2 Storage Conditions 1.4 1.4.1.6

Finding: The facility did not receive product returns, any product returns are sent back to the manufacturer. The co-packer would only be contacted by the manufacturer who is their customer.

.

. 3 Storage Conditions 1.4 1.4.2.1

Finding: Segregation of packaging materials from finished products was observed.. .

4 Raw Material/Finished Product Inventory 1.5 1.5.1.1Finding: Ingredients and packaging materials were rotated on a First-In, First-Out basis. The facility will package the product when

received from their customer and their process will be JIT.. .

5 Pallets 1.6 1.6.2.2Finding: Slip sheets were used on pallets and between pallets to protect materials from damage, as required by the customer.

.

. 6 Sampling Procedures 1.10 1.10.1.1

Finding: Finished product samples will be taken at the facility. Documented sampling procedures to prevent contamination of the product and the sample taken were defined for the facility.

.

. 7 Raw Material Transfer 1.12 1.12.2.2

Finding: Packaging is inspected and cleaned prior to entry into processing areas.. .

8 Product Identification 1.18 1.18.1.1Finding: Work-in-progress and finished product materials were properly identified and dated.

.

. 9 Finished Product Transportation 1.26 1.26.1.9

Finding: Written transportation breakdown procedures were on file at the product manufacturer, distributor or shipping company. The co-packer sends its packaged product back to the manufacturing plant for distribution.

.

. 10 Hand Washing Facilities 1.27 1.27.1.2

Finding: Single use towels were used at this facility.. .

11 Hand Washing Facilities 1.27 1.27.1.3Finding: Purchased hand sanitizers were provided.

.

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. 12 Washrooms, Showers, and Locker Rooms 1.28 1.28.2.1

Finding: A defined locker inspection program was documented and was to be carried out every six months.. .

13 Personal Hygiene 1.29 1.29.2.1Finding: Hand washing practices were periodically monitored for effectiveness, the program will be performed every six month.

.

. 14 Work Clothes, Changing Facilities, and

Personnel Areas 1.30 1.30.1.1

Finding: Personnel were observed wearing suitable clothing or uniforms that were clean. Any person working in the processing/packaging room wear lab coats.

.

. 15 Work Clothes, Changing Facilities, and

Personnel Areas 1.30 1.30.1.8

Finding: Protective clothing was by a contract service.. .

16 Health Conditions 1.33 1.33.1.2Finding: Cuts and grazes were covered by metal detectable bandages.

.

. 17 Filling, Capping and Sealing 1.37 1.37.1.1

Finding: Performance of filling and sealing operations appeared to be consistent with defined procedures.. .

18 Security Equipment 2.3 2.3.2.1Finding: Some measures were taken to maintain facility security. Security strategies included controlled gate access, controlled

parking, locked doors, limited access to sensitive areas, surveillance cameras, guard services or security patrols of industrial park, truck seals/locks, employee screening, and awareness and training programs.

.

. 19 Air Makeup Units 2.10 2.10.1.5

Finding: Filters were in place in air makeup units which were rated MERV 8.. .

20 Cross Contamination Prevention 2.14 2.14.1.5Finding: Partitions, doors, or other barriers were used to segregate cleaning areas from production areas.

.

. 21 Integrated Pest Management (IPM) Program 4.1 4.1.2.1

Finding: Responsibilities were defined for the IPM contractor.. .

22 Facility Assessment 4.2 4.2.1.1Finding: The annual facility assessment was documented and current, performed 3/13/13.

.

. 23 Credentials and Competencies 4.5 4.5.1.2

Finding: Regulation does require certification or licensing of IPM personnel. Certification documentation and training records were provided and current.

.

.

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24 Credentials and Competencies 4.5 4.5.2.1Finding: Evidence of competency of the service provider was provided through the current license.

.

. 25 Trend Analysis 4.9 4.9.1.1

Finding: Service records were documented and reflected current levels of pest activity and recommendations for Corrective Actions. No pest activity was noted during the initial servicing performed in the facility.

.

. 26 Insect Light Traps 4.13 4.13.2.1

Finding: ILT light tubes were changed on an annual basis at the beginning of the active season, lights installed 6/25/13.. .

27 Training and Education 5.5 5.5.1.5Finding: Annual refresher training was provided and current, performed 6/21/13.

.

. 28 Allergen Control Program 5.11 5.11.1.1

Finding: A documented Allergen Control Program was in place to address the allergens used or handled at this facility. The facility presently does not have any allergen containing products.

.

. 29 Glass, Brittle Plastics, and Ceramics Program 5.12 5.12.1.3

Finding: Included in the policy was a procedure to handle any breakage in the facility. A list of all essential glass, brittle plastics, and ceramics was developed, and scheduled inspections were conducted semi-annually.

.

. 30 Recall-Withdrawal Program 5.19 5.19.1.4

Finding: The mock recall exercise included the first level of distribution outside of the control of the facility. The facility has not done a mock recall since no product has been manufactured or packaged.

.

. 31 Recall-Withdrawal Program 5.19 5.19.1.6

Finding: The written Recall-Withdrawal Program included Recall-Crisis Management team contact information, roles and responsibilities of team members, location of the Traceability Program, key regulatory agency contact information, supplier and customer emergency contact information. A sample recall-withdrawal notification letter was on file from the company who owns the packaging line technology.

.

. 32 Specification Program 5.22 5.22.1.1

Finding: Appropriate specifications were on file for food contact packaging materials and finished products evaluated during the inspection.

.

. 33 Letters of Guarantee or Certifications 5.23 5.23.1.1

Finding: Letters of Guarantee or Certifications for received materials and finished products were on file and current for materials reviewed during the survey. All product presently being packaged are sample/research packages not for sale.

.

. 34 HACCP Program 5.25 5.25.1.1

Finding: A Hazard Analysis Critical Control Point (HACCP) Program was developed and implemented for processes and process lines and incorporated Prerequisite Programs. The risk analysis found no CCP's in the present packaging process.

.

.

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35 Release Procedures 5.27 5.27.1.1Finding: Release procedures were defined for raw materials or finished products used at this facility. The facility co-packs for

various manufacturers, they receive the product to be packaged and once packaged it is returned to customer for sale and distribution.

.

. 36 Water Quality 5.29 5.29.1.4

Finding: No water, ice, and steam water were used for food contact..

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Standards without identified Risks or FindingsBased on random review and observation samplings at the time of the inspection, the facility appears to be meeting the requirements of the following Standards:

Standard Standard # Standard Goal

Rejection of Shipments/Receipt of Dry Goods

1.1 Random review of records and programs related to safeguarding of food products by identifying and barring entry to potentially contaminated raw materials indicate they met the requirements of the standard as applicable to this site.

Rejection of Shipments/Receipt of Perishables

1.2 Random review of the records and programs related to receipt of perishable products by identifying and barring entry to potentially contaminated raw materials indicate they met the requirements of the standard as applicable to this site.

Storage Practices 1.3 Materials appeared to be stored in a way that met the program requirements as defined by this site, as well as the applicable requirements in the standard.

Storage Conditions 1.4 Raw materials and finished products appeared to be stored in a clean storage area and were protected from contamination as observed during the inspection.

Raw Material/Finished Product Inventory 1.5 Raw material and finished product inventories appeared to be maintained at a reasonable volume. Random review of materials did not identify aged or infested materials during the inspection.

Pallets 1.6 Pallets examined were found to be clean and well maintained.

Sampling Procedures 1.10 Sampling procedures were defined and developed with consideration to protection of product.

Raw Material Transfer 1.12 Observation indicated that raw materials were transferred, handled, and managed at the time of inspection to prevent contamination of materials. This included transfer of materials to point of use and transfer of materials to secondary containers as applicable to the facility.

Foreign Material Control Devices 1.15 Foreign material control devices, such as metal detectors and magnets, were installed to provide foreign material control. Testing of the devices in service during the inspection and random review of the documentation of checks of these devices and Corrective Action documentation indicated that the Foreign Material Control Programs were being followed as defined for the facility.

Waste Material Disposal 1.16 Waste material and waste material removal were managed to avoid product contamination.

Product Identification 1.18 Random review indicated that raw materials, rework, work-in-progress, and carry-over as applicable to the facility were identified to prevent misuse.

Workspace Arrangement 1.19 Workspace areas reviewed during the inspection were found to be clean and well maintained.

Hand Contact 1.21 Hand contact with product observed during the inspection was limited where possible and

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practical to prevent contamination.

Cross Contamination Prevention 1.23 Incompatible or hazardous materials observed during the inspection appeared to be segregated and handled to prevent product contamination.

Hand Washing Facilities 1.27 Hand washing facilities examined during the inspection appeared to be appropriately located, functional, and stocked to allow hand washing to occur.

Washrooms, Showers, and Locker Rooms 1.28 Employee welfare areas examined were maintained in good condition.

Personal Hygiene 1.29 No personal hygiene practices issues were identified during the inspection.

Work Clothes, Changing Facilities, and Personnel Areas

1.30 Appropriate clothing or uniforms were observed to be clean and in good condition. Changing facilities were provided.

Personal Items and Jewelry Control 1.32 No issues with the control of jewelry or personal items were identified during the inspection.

Health Conditions 1.33 Health policies were defined for the facility. No issues that were inconsistent with these policies were identified.

Non-Facility Personnel 1.34 Non-facility personnel were observed to be in compliance with the facility defined GMP Programs.

Multiple-Service Shipping Containers 1.35 Multiple service shipping containers appeared to be cleaned and maintained to prevent contamination of products.

Glass Container Breakage 1.36 When glass containers were broken, procedures were in place and appeared to be effective in dealing with breakage issues.

Filling, Capping and Sealing 1.37 Monitoring of filling, capping and sealing operations appeared to be monitored and consistent with defined specifications.

Facility Location 2.1 No evidence of issues from local activities or the facility location were identified during the inspection.

Outside Grounds and Roof 2.2 Facility grounds appeared to be well maintained. No issues were identified.

Security Equipment 2.3 Physical security measures were implemented at this facility.

Layout 2.4 No issues with placement of equipment and structures were identified. Appropriate access for cleaning, inspection, and maintenance activities was noted.

Floors 2.5 Floor surfaces observed during the inspection were found to be in good condition.

Ceilings and Overhead Structures 2.8 Overhead structures that could be examined were found to be clean and in good condition.

Glass, Brittle Plastics, and Ceramics Control

2.9 No issues with glass, brittle plastics, or ceramics were identified during the inspection.

Air Makeup Units 2.10 Filters and screens examined during the inspection were found to be well maintained and in good condition.

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Leaks and Lubrication 2.12 Catch pans or other devices were provided to protect product from contamination from lubrication or leaks.

Lubricants 2.13 Food-grade lubricants were identified for use on food processing and packaging equipment and were labeled and segregated from non food-grade lubricants.

Cross Contamination Prevention 2.14 Segregation of operations based on process flow appeared to be practiced as observed during the inspection.

Temporary Repair Materials 2.16 Temporary repairs noted during the inspection were consistent with the facility defined program.

Compressed Air/Product Contact Gases 2.18 Compressed air or other gases were used in contact with product or product contact surfaces. Random review of records and observation indicated that filters were maintained or that purity was suitable to prevent contamination of product or product contact surfaces.

Transporting Equipment 2.19 Transporting equipment appeared to be well maintained at the time of the inspection.

Parts Storage 2.20 Parts were found to be clean and properly stored at the time of the inspection.

Hand Washing Facilities Design 2.21 Hand washing facilities were provided and were observed to be operational during the inspection.

Cleaning 3.1 Cleaning appeared to be completed in a way to prevent contamination of raw materials, products, and equipment.

Food Contact Cleaning Compounds and Sanitizers

3.2 Approval and verification procedures were in place for cleaning compounds and sanitizers used at the facility for food contact cleaning. Approval documentation was provided for the chemicals that were selected and reviewed.

Equipment and Tools 3.3 Cleaning tools and equipment appeared to be managed and maintained to prevent product contamination. No issues were identified.

Daily (Housekeeping) Cleaning 3.4 No issues were identified with daily housekeeping practices observed during the inspection.

Product Zone Cleaning 3.5 Review of cleaning of product contact surfaces observed during the inspection indicated that these processes appeared to be effective. No issues were observed or identified.

Non-Product Zone and Support Area Cleaning

3.6 Non-product zone and support area cleaning appeared to be completed. No issues were identified.

Integrated Pest Management (IPM) Program

4.1 A written IPM Program outlining controls and processes to minimize pest activity were defined.

Facility Assessment 4.2 An annual assessment of the IPM Program was documented and current.

Signed Contracts 4.4 Signed contracts between the facility and the external service provider defined the requirements for pest management activities for this facility.

Credentials and Competencies 4.5 Qualifications examined for selected IPM service providers were documented and current.

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Pesticide Documentation 4.6 Pesticide labels and chemical safety data sheets were provided for the pesticides randomly examined during the inspection.

Pesticide Application Documentation 4.7 Pesticide application documentation was current and provided records to identify, document, and verify use of pesticides randomly examined during the inspection.

Trend Analysis 4.9 Service records of monitoring devices and pest sightings reviewed appeared to be used to identify and eliminate areas of pest activity as noted by the lack of significant activity observed during the inspection.

Monitoring Device Documentation 4.10 Monitoring devices were mapped and maintained to ensure proper placement and monitoring for pest activity and trending. The map appeared to be current based on observation during the inspection.

Exterior Rodent Monitoring Devices 4.11 Exterior rodent control devices were placed and those randomly reviewed were maintained to provide rodent monitoring and to deter entry into the facility.

Interior Rodent Monitoring Devices 4.12 Interior rodent monitoring devices were placed and those randomly reviewed were maintained to identify and capture rodents that have gained access to the facility.

Insect Light Traps 4.13 Insect light traps were provided and those reviewed were maintained to identify and monitor flying insects in the facility.

Bird Control 4.15 Bird control activities were addressed and the lack of activity noted during the inspection indicated that the program was effective.

Wildlife Control 4.16 No issues with identification or elimination of wildlife habitat were noted.

Pest Habitat 4.17 No evidence of rodent, bird, insect, or other pest issues were identified during the inspection.

Written Policy 5.1 A written policy emphasizing the facility's commitment to provide safe and legal food products was documented for this facility.

Accountability 5.2 Management authorization and support of supervisory compliance to programs, laws, and regulations was defined for this site and appeared to be implemented.

Support 5.3 Human and financial resources were provided to support implementation of the Food Safety and Prerequisite Programs.

Written Procedures 5.4 Written procedures randomly reviewed for food safety activities at the facility defined owners, actions, and timelines.

Written Procedure Audits 5.7 Written procedure audits were documented to validate the appropriateness and implementation of procedures defined for this site. Records randomly reviewed indicated that audits were conducted and current.

Customer Complaint Program 5.8 A Customer Complaint Program was implemented to respond to customer concerns. Protocols were in place to ensure that food safety issues were responded to in a prompt and effective manner, whether it be at the facility level or as managed by corporate.

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Chemical Control Program 5.9 A documented Chemical Control Program was implemented to provide a centralized approach to manage and control purchase and use of nonfood chemicals. Random review of chemicals and program requirements indicated that this program had been implemented as applicable for this facility.

Allergen Control Program 5.11 Allergen controls were implemented to identify allergen control throughout the process from receiving to distribution of product. Random review of the program, records, and observations during the inspection indicated that the program was implemented.

Glass, Brittle Plastics, and Ceramics Program

5.12 A documented Glass, Brittle Plastics, and Ceramics Program was provided to identify processes that prevent contamination of product. There were no identified deficiencies noted during the inspection to indicate that the program was ineffective.

Cleaning Program 5.13 A Cleaning Program with schedules and procedures for accomplishing cleaning tasks critical to maintenance of the food processing environment was documented. Random review of schedules and cleaning procedures, in addition to observations, indicated that the program appeared to be effective.

Receiving Program 5.15 The Receiving Program implemented at the facility outlined and identified requirements for the raw materials received at this site. Random review of the program and documentation of receipt of materials indicated that materials receipts were consistent with the defined program requirements.

Regulatory Affairs and Inspection Program 5.16 A documented Regulatory Affairs and Inspections Program provided instructions for handling of regulatory, third party, and customer inspections.

Traceability Program 5.18 The written Traceability Program defined the methodology to allow quick location of suspect raw materials, food contact packaging materials, rework, and related finished products.

Recall-Withdrawal Program 5.19 The written Recall/Withdrawal Program documented the procedures for quick and controlled recovery of product from the market. Random review of the records and mock recovery exercises indicated that the program was implemented as defined for this facility.

Nonconforming Product Program 5.20 The Nonconforming Products Program defined the guidelines for isolation, investigation, and disposition of raw materials, packaging materials, work-in-progress, returned goods, and finished products as applicable to the facility. Random review of records and observations during the inspection did not identify any current deficiencies with this program.

Approved Supplier Program 5.21 Evaluation of goods and services that impact the facility's food safety programs were managed as part of the Approved Supplier Program. Materials randomly selected and reviewed during the inspection appeared to meet program requirements.

Specification Program 5.22 Specifications that defined food safety requirements for raw materials, food contact packaging materials, processing aids, work-in-progress, and finished products were maintained, as applicable to this facility. Random review of materials indicated that facility defined program requirements were currently being met.

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Letters of Guarantee or Certifications 5.23 Statements of assurance in the form of letters of guarantee or certifications were provided to indicate compliance to regulatory requirements for received materials and finished products. Records randomly reviewed indicated that the facility was currently meeting their program requirements.

HACCP Program 5.25 A HACCP Plan that evaluated the hazards associated with the raw materials and processes related to product or food category was defined and implemented for the facility. This included the hazard analysis and identification of critical control points, as applicable, to prevent, eliminate, or reduce these hazards to an acceptable level. Random review of records indicated that the facility met the CCPs requirements or that appropriate deviation procedures were implemented as identified by the program.

Release Procedures 5.27 Release procedures as defined for this facility were implemented to ensure that materials were checked for food safety hazards prior to release and shipment to the customer.

Design Standards 5.28 Structural and equipment design standards were implemented to aid in maintenance of food safety programs.

Water Quality 5.29 Water, water sources, and water management strategies were implemented to ensure safe water for product contact and use. Random reviews of the records indicated that programs were implemented.

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Standards Not ApplicableStandard # Standard Name

1.7 Designated Rework Areas

1.8 Dust Collection and Filtering Devices

1.9 Bulk Material Handling

1.11 Processing Aids

1.13 Bulk Material Sifting

1.14 Bulk Liquid Materials

1.17 Ingredient Scoops

1.20 Single-Service Containers

1.22 Temperature-Sensitive Materials

1.24 Containers and Utensils

1.25 Cans, Bottles, and Rigid Packaging

1.31 High-Risk Clothing Management

1.38 Examination of Materials

2.6 Drains

2.17 Temperature Measuring Devices

2.22 Bulk Systems and Unloading Areas

2.23 Ammonia Control

2.24 Wastewater Treatment and Sewage Disposal

3.7 Clean in Place (CIP) Systems

4.3 Other Guidelines

4.8 Pesticide Control

4.14 Pheromone Monitoring Devices

5.10 Microbial Control Program

5.24 High-Risk Processing Record Program

5.26 Specialized Testing

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