This document provides information about ABC Research Laboratories and their services for resolving FDA import detentions. It discusses the detention process, including why products may be detained under import alerts and the "red list" and "green list" system. It outlines the documents needed for sampling and testing, the testing process, and how to submit results to the FDA. It also explains that importers need 5 consecutive clean entries and to file a petition to be removed from the "red list," which may require working with an import attorney. The document encourages subscribing to their blog for more food safety information and ends thanking attendees.

1. I GOT DETAINED BY FDA.
NOW WHAT?
Annie Hughes
annieh@abcr.com
@anniehughes19
Gillian Dagan
gillian@abcr.com
@gatorgill

2. About us!
We are here to help!
Annie Hughes
annieh@abcr.com
@anniehughes19
Gillian Dagan
gillian@abcr.com
@gatorgill

3. 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!

4. 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

5. Introduction to ABC
Research
Established in 1967
One of the largest & fully comprehensive
ISO 17025 accredited independent
food testing laboratories in the United States

6. 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

7. FDA Import Detention Resolution
Testing and Services
• ABC’s dedicated FDA Detention Resolution
team: fda@abcr.com
– 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

8. 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

9. 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.

10. 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

11. 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

12. 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

13. 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

14. Questions and Answers
We are here to help!
Annie Hughes
annieh@abcr.com
@anniehughes19
Gillian Dagan
gillian@abcr.com
@gatorgill

15. 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!

16. THANK YOU!