FDA WARNING_LETTER - Kwong Yet Lung Co., Inc. - May 07, 2014

An FDA inspection of Kwong Yet Lung Company's seafood processing facility from May 5-7, 2014, revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (GMP) regulations (21 CFR Part 110). Consequently, the firm's frozen ready-to-eat crab legs, frozen breaded shrimp, refrigerated pasteurized crabmeat, smoked salmon, raw mahi-mahi, and raw tuna were deemed adulterated. Additionally, certain products were found to be misbranded under 21 CFR Part 101.

Key violations included the absence of a HACCP plan for frozen breaded shrimp to control undeclared allergens and additives, and the HACCP plan for "CUT SEAFOOD" failing to list allergens as a hazard. The firm also had inadequate monitoring procedures for C. botulinum toxin formation in "Fresh MAP Fish" and failed to record monitoring observations for metal inclusion. Process monitoring equipment, including cooler gauges and handheld thermometers, were improperly calibrated. Sanitation conditions were insufficiently monitored, affecting food contact surfaces, sanitizing solution, gloves, and outer garments.

Labeling deficiencies included "Breaded Shrimp Butterfly Tail off" being adulterated due to unsafe, uncertified color additives (Tartrazine, Sunset Yellow FCF) and misbranded for not properly declaring artificial coloring. "King Neptune Breaded Shrimp Butterfly T/ON" was misbranded due to undeclared ingredients. Furthermore, product labels lacked a full name and address (21 CFR 101.5) and correct net quantity of contents statements (21 CFR 101.105(b)(1)).

The FDA requires prompt corrective action and a written response within fifteen working days, including documentation of corrections. Failure to comply may result in regulatory actions such as seizure or injunction, and the firm may be assessed re-inspection fees.