Nearly 25% of 2014 Warning Letters Issued to Seafood Industry

A warning letter issued by the US FDA is the most common and widely used enforcement tool. It is also among the most public. Every couple of weeks or so the US FDA updates its public warning letter database with “recently posted” actions. Reading those letters over the past couple of months a striking trend emerged. Nearly every update included at least one seafood company, often several. This morning’s updated prompted an accounting to assess just how many of the 110 2014 warning letters issued to date were for seafood facilities. The results are striking 23 warning letters were issued in this first quarter of 2014 to seafood facilities. That is nearly 25% of the letters issued were addressing violations made by seafood facilities.


Nearly every letter cites a deficinecy with a facilities Hazard Analysis and Critical Control Point (HACCP) plan. Many letters address a failure to properly ensure imported seafood products meet US FDA standards. For example, this letter to Ocean Wave Products, Inc.:

You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation, to comply with 21 CFR123.12(a)(2)(ii). However, your firm did not perform an affirmative step for frozen Hilsa (shad) fish manufactured by (b)(4), located in (b)(4).

Other letters look at failures to identify critical limits or properly identify hazards as part of a hazard analysis. For example,

You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3).

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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