FDA WARNING_LETTER - Japanese Specialty Food Distributors Ltd, Co. - August 07, 2014

On August 29, 2014, the FDA issued a Warning Letter to Japanese Specialty Food Distributors Ltd, Co. following an inspection of their seafood processing facility in Brookfield, CT, conducted from July 29 to August 7, 2014. The inspection revealed 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 frozen vacuum-packaged raw salmon and tuna products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to preparation, packing, or holding under insanitary conditions.

Key violations included: 1. **Lack of HACCP Plan:** The firm did not have a written HACCP plan for frozen vacuum-packaged ready-to-eat raw salmon to control food safety hazards such as parasites, pathogens, and *Clostridium botulinum*, violating 21 CFR 123.6(a) and (b). 2. **Inadequate Sanitation Monitoring:** The firm failed to monitor sanitation conditions and practices with sufficient frequency, as required by 21 CFR 123.11(b). This was evidenced by a lack of sanitation operating procedures, monitoring, and records for water safety, food contact surface cleanliness, cross-contamination prevention,