FDA Regulatory Update
Seafood Products Association
Processors Workshop
March 4, 2014
Miriam Burbach
Compliance Director
Seattle District Office, U.S. FDA
• Top Ten Deficiencies
• Environmental Samples
• Warning Letters
• Imported Seafood
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21 CFR123.11(b)
21 CFR123.6(b)
21 CFR123.11(c)
21 CFR123.6(b)
21 CFR123.6(c)(4)
21 CFR123.6(c)(1)
21 CFR123.6(c)(2)
21 CFR123.6(c)(3)
21 CFR123.6(c)(5)
21 CFR123.6(d)
Nationwide 1666 1177 833 846 851 816 792 819 777 618
Seattle 215 94 79 65 45 61 82 50 40 45
0
200
400
600
800
1000
1200
1400
1600
1800
2000
Seattle District Comparison of Top 10 Nationwide Deviations
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Importers
Avoid Delays and Extra Costs
• Check the Import Alerts lists prior to
importing products – http://www.accessdata.fda.gov/cms_ia/industry_16.ht
ml
• There are nearly 50 import alerts that do
or may pertain to seafood
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Import Alerts
• Is your regular supplier on import alert but your private lab testing has been finding no problems?
• Refer to the text of the particular import alert for specific guidance on how to get the manufacturer off the List
• Also refer to Chapter 9.6 of the Regulatory Procedures Manual
• You are allowed to submit the petition on behalf of your foreign supplier, or they can submit it.
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Petitions for Import Alerts
• Petitions - detailed and well-thought out
cover letter with supporting evidence (e.g.
past good lab reports); some may
necessitate more, such as HACCP
verification
• How-to questions and petition submissions
do not go through the local FDA office, but
rather Division of Import Operations (DIO):
– DIO 301-796-0356
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Imported Seafood
• Additional time-and money-saving tips regarding imported seafood: – Make sure the filer enters the correct foreign
manufacturer. Does it match with the paper entry documents and invoice? Mis-matches will result in your product being stopped.
– Importing returned US Goods? Have filer note “USGR” in description line and provide documentation from foreign country or entity showing reason for their refusal and return. Back-tracking on this can turn into more time and effort than noting it up front.
– Direct exports and returns by truck to Canada: save yourself CBP (Customs) fines by having the trucker stop to have the export paperwork signed off as they cross the border.
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Importer HACCP Verification
• Importer HACCP Verification of your foreign suppliers – Requirement under 21 CFR 123.12
• If your product is not obtained from a country that has an active MOU for inspectional compliance, then you will need to:
• Implement and keep on file written verification procedures; these are checked during a FDA/State domestic inspection of your facility
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Importer HACCP Verification
• HACCP Guarantee Letter from your supplier. [This is only under choice D, as mentioned below.]
• Your specifications for a safe product.
– What safety standards do you expect in the product they supply to you?
– This is based on the hazards associated with the product/process; e.g. acceptable microbial load, acceptable %WPS content, acceptable Aw, et cetera.
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• Documentation of your chosen Affirmative
Step (there are six choices, A through F,
under 21 CFR 123.12(a)(2)(ii))
– Most firms select Choice D. This would
include obtaining a HACCP Guarantee
Letter from your supplier, and a copy of
their HACCP plan.
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Importer HACCP Verification
• Optional: – Your firm’s statement of what you are doing to address 21
CFR 123.12, such as what Affirmative Step you have chosen
• Remember that your supplier is required to review and update their HACCP plans at least annually
• If your Affirmative Step is to get their HACCP plans, make sure the documentation they send you is current
• Importer responsibilities – Review the HACCP plans your supplier gives you, and
dialogue with them to make any needed corrections
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Importer HACCP Verification
• Additional Reference:
• http://www.fda.gov/InternationalPrograms/
Agreements/MemorandaofUnderstanding/
default.htm
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