FDA WARNING_LETTER - Wing Kee Foodstuff Co. - June 21, 2011

On August 13, 2012, the FDA issued a Warning Letter to Wing Kee Foodstuff Co. following an inspection from June 18-21, 2011, at their San Francisco facilities. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically concerning imported fish and fishery products.

As an importer, Wing Kee Foodstuff Co. is required by 21 CFR 123.12(d) to ensure that all imported fish and fishery products comply with 21 CFR Part 123. The FDA found that the firm failed to implement an affirmative step to ensure imported products were processed in accordance with FDA's seafood HACCP regulations, violating 21 CFR 123.12(a)(2)(ii).

Specific products cited for this violation include dried conch slices, dried flatfish, dried cuttlefish, dried whole eviscerated pollock, dried shrimp, dried octopus, and dried oyster, imported between December 2011 and May 2012 from Hong Kong. These products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

The FDA acknowledged the firm's verbal responses to the Inspection