FDA Requirements for Product Specifications
Started by Culinary Collaborations, Oct 15 2019 07:29 PM
I receive the daily FDA alerts and this was part of a warning letter issued to a Seafood Importer.
You must have product specifications that are designed to ensure that the fish and fishery products that
you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm
imports a variety of frozen, and dried seafood products including the following: frozen red seabream
loins, frozen yellowtail, frozen pacific squid, frozen cuttlefish, frozen monkfish, frozen breaded horse
mackerel, frozen prepared pacific herring, dried shaved mackerel & scad, dried sardine & scad, and dried
shaved bonito and you do not have product specifications to address the hazards of histamine;
environmental chemicals; aquaculture drugs; potential metal inclusion; undeclared food allergens/food
additives; and pathogen growth and potential toxin formation including, for example, Clostridium
botulinum and Staphylococcus aureus toxin formation.
you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm
imports a variety of frozen, and dried seafood products including the following: frozen red seabream
loins, frozen yellowtail, frozen pacific squid, frozen cuttlefish, frozen monkfish, frozen breaded horse
mackerel, frozen prepared pacific herring, dried shaved mackerel & scad, dried sardine & scad, and dried
shaved bonito and you do not have product specifications to address the hazards of histamine;
environmental chemicals; aquaculture drugs; potential metal inclusion; undeclared food allergens/food
additives; and pathogen growth and potential toxin formation including, for example, Clostridium
botulinum and Staphylococcus aureus toxin formation.
My question relates to product specifications. We have specifications for our seafood products including Tolerance Defects (define your sample size and tolerances) - Would this meet the criteria?
If not, any direction where I might find the FDA requirements for Seafood Product specifications in general and specifically relating to Sec 402 Adulteration?
Thanks so much for your help.
Have a wonderful day!
Renee
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FDA’s requirement for seafood product specifications refers only to food safety hazards that would be addressed in a HACCP plan. So, for instance, if you are importing tuna, then you must have a specification that addresses the maximum level of histamine in the product. Most companies will combine the food safety and quality aspects into one specification.
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