Sunday 23 July 2017

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). A critical limit is defined in 21 CFR 123.3 (c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.”  However, your firm’s HACCP plan for scombroid species lists critical limits at the receiving CCP that are not adequate to control the scombrotoxin formation (histamine) hazard.  Your critical limits are listed as: “(b)(4)”. During the inspection we noted that your firm is not performing a sensory exam on any incoming scombroid species.   – Portland Fish Exchange Warning Letter

or

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). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plan for cooked, ready-to-eat salmon pies lists a critical limit, “Internal temperature of pie of (b)(4)°F”at the cooking critical control point that is not adequate to control pathogenic bacteria survival through cooking. This critical limit has not been established by a scientific study and there is no assurance that it will eliminate or reduce this hazard to an acceptable level. – E. W. Mailhot Sausage Company Warning Letter

The letters all cite to a significant violation of HACCP which renders the seafood products adulterated. The number of violations suggest either an increase in FDA scrutiny over seafood products or a pervasive lack of understanding or insufficient monitoring of HACCP plans by facilities. In either case it will be worth watching to determine if this is an emerging industry trend.

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