FDA WARNING_LETTER - T.H. Seafood - April 27, 2008

On April 15-27, 2008, the FDA inspected a seafood processing facility at 7901 2nd Avenue South, Seattle, Washington, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). The firm's Scombroid-forming seafood and canned crabmeat products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions.

Specific violations included: 1. **Inadequate HACCP Plan (21 CFR 123.6(c)(4)):** The revised canned crab meat HACCP plan (dated 04-17-08) lacked monitoring procedures and frequencies for the receiving critical control point to control pathogen growth and toxin formation, specifically regarding monitoring for the presence of ice. 2. **Inappropriate Corrective Actions (21 CFR 123.7(b)):** The corrective action plan for crabmeat at the storage critical control point, "Recall product in compliance with recall notifications," was insufficient. It failed to address how affected product still at the facility would be handled to prevent it from entering commerce or how the cause of the deviation would be corrected to prevent recurrence