FDA WARNING_LETTER - Prime Time Seafood, Inc - June 29, 2010

The FDA inspected Prime Time Seafood, Inc. in Los Angeles, CA, from June 22-29, 2010, and identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (GMP) regulation (21 CFR Part 110). Consequently, the firm's tuna and wahoo products are deemed adulterated. Key deficiencies include inadequate HACCP plans for histamine species fish, specifically concerning monitoring procedures and frequencies at the storage critical control point (21 CFR 123.6(c)(4)), and critical limits at the receiving critical control point (21 CFR 123.6(c)(3)). The firm's corrective action plan for histamine species at storage was found inappropriate (21 CFR 123.7(b)), and monitoring procedures listed in the HACCP plan were not implemented (21 CFR 123.6(b) and (c)(4)). Sanitation conditions and practices were not monitored with sufficient frequency to ensure GMP compliance (21 CFR 123.11(b)), evidenced by issues like rough cutting boards and improper hose use. For imported products, the firm failed to provide product specifications for fresh wahoo (21 CFR 123.12(a)(2)(i)) and did not implement affirmative steps for imported bluefin tuna (21 CFR 123.12(a)(2)(ii)). The FDA warns that failure to promptly correct these violations could lead to refusal of admission, detention without physical examination, seizure, or injunction. A written response outlining specific corrective actions and supporting documentation is required within fifteen working days.