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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THANK YOU!

MIRIAM BURBACH

22215 26TH AVE SE, SUITE 210

BOTHELL, WA 98021

425-302-0420

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