i got detained by the fda. now what?
DESCRIPTION
If you import food into the United States, one of your biggest nightmares is a detention by the FDA. As regulations continue to tighten, the potential for a detention is higher than ever. What do you do when your company faces one? We know there are a lot of questions, and our FDA detention resolution experts Gillian Dagan PhD and Annie Hughes are here to help. This webinar will discuss: What to do to be prepared before the detention happens What documentation you need to have ready when detained Who you should contact immediately following a DWPE How to expedite your detention and get your product back to market And more!TRANSCRIPT
Annie [email protected]@anniehughes19Gillian Dagan
[email protected]@gatorgill
I GOT DETAINED BY FDA. NOW WHAT?
About us!
We are here to help!
Annie [email protected]@anniehughes19
Gillian [email protected]
@gatorgill
Subscribe to our Blog!
www.foodtestingexperts.com• Stay up to date with the latest food safety news, best
practices, guides and more from your favorite food testing experts.
• Join our growing community of food industry experts and enthusiasts by subscribing to the ABC Research Laboratories Food Testing Experts blog. Get informative and entertaining articles straight to your inbox when you subscribe!
OVERVIEW
• Introduction to ABC Research and our FDA detention resolution team
• The detention process• Important documents• How to be removed from the “Red
List.”• Live question and answer session
Introduction to ABC Research
Established in 1967 One of the largest & fully comprehensive
ISO 17025 accredited independent food testing laboratories in the United States
FDA Import Detention Resolution Testing and Services
• An Exclusive Team dedicated to the FDA detention process– 1st goal – get your product to market
• DWPE – testing for all Import Alerts• RED LIST – increased cost & delays• GREEN LIST – ultimate goal
• Expedited sampling throughout the U.S.• With the Compliance Officers and FDA Review Labs
Nationwide– Established/recognized/accepted– Respected for our science and packet submission details
• Services & guidelines for removal from DWPE• Highly regarded by FDA attorney’s and Customs Brokers
Nationwide
FDA Import Detention Resolution Testing and Services
• ABC’s dedicated FDA Detention Resolution team: [email protected]– All emails should be sent to this email
address as it includes everyone at ABC-R who is involved with your detentions including business development director, operations, and scientists
– Guarantees that your email will be responded to in an efficient manner
The Detention Process
• Why do certain manufacturers get detained?– FDA has evidence that the commodity,
manufacturer, shipper, or country is potentially in violation of the Food, Drug, and Cosmetic Act:• Manufactured, processed or packed under insanitary
conditions• Product is adulterated or misbranded• Record keeping requirements have not been
compliant
• The FDA issues Import Alerts which allows them to detain products they suspect are in violation of the Food, Drug, and Cosmetic Act:
http://www.accessdata.fda.gov/cms_ia/ialist.html
The Detention Process
• The Import Alerts may also contain a “Red List” and a “Green List”– “Red List”
• List of specific commodities and manufacturers who will be automatically detained when product enters the United States.
– “Green List”• List of specific commodities and manufacturers who
have been removed from the “Red List” and will not be detained; product will be released into commerce as these manufacturers have met the criteria for exclusion from the DWPE list.
DOCUMENTS TO GATHER
Once you have been detained, ABC will need the following documents to schedule the sampling and testing of your product:• Notice of Action• Bill of Lading• Customs Form 3461• Commercial Invoice• Packing List
Your Customs Broker should be able to provide you with this information.
The Detention Process
• ABC Research will prepare a quote for your review which will include the cost of sampling and testing
• Once you have approved the quote, you will need to send a release to the warehouse informing them that we will be colleting samples and will need access to the entire detained lot
• We will schedule the sampling with your warehouse and will only pull the number of samples required by the FDA for your particular detention
• Samples will be shipped to ABC-R via FedEx next day
• Preparations and testing will begin
The Detention Process
• As soon as the testing is completed, we will email you the results with an Importer’s Statement
• You will need to complete and return the importer’s statement which will indicate that you give permission to ABC-R to submit the results and required packet to the FDA
• FDA will review the packet and send you notification of their decision
Getting off the “Red List”
• To be removed from the “Red List”– You must have at least 5 consecutive clean
entries– File a petition to be removed from the “Red
List” which will include root cause analysis and a list of corrective actions that have been implemented
– ABC Research recommends consulting with an import attorney as they can help to expedite this process
Questions and Answers
We are here to help!
Annie [email protected]@anniehughes19
Gillian [email protected]
@gatorgill
Don’t forget to subscribe!
www.foodtestingexperts.com• Stay up to date with the latest food safety news, best
practices, guides and more from your favorite food testing experts.
• Join our growing community of food industry experts and enthusiasts by subscribing to the ABC Research Laboratories Food Testing Experts blog. Get informative and entertaining articles straight to your inbox when you subscribe!
THANK YOU!