FDA WARNING_LETTER - Martinez Produce & Seafood Inc - January 14, 2021

The FDA inspected Martinez Produce & Seafood Inc. from January 5-14, 2021, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their imported, refrigerated fin fish, including tuna, mackerel, flounder, and salmon, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deviations include the firm's failure to have a HACCP plan for fresh tuna and salmon in reduced oxygen packaging to control Clostridium botulinum (21 CFR 123.6(a), (b)), and failure to implement an affirmative step for imported fish to ensure HACCP compliance (21 CFR 123.12(a)(2)(ii)). The firm also failed to monitor current Good Manufacturing Practices (CGMPs) with sufficient frequency (21 CFR 123.11(b)), specifically regarding proper cleaning and sanitization of equipment (21 CFR 117.35(a)) and protecting finished food from contamination (21 CFR 117.80(c)(6)). The FDA noted that 21 CFR Part 110 is obsolete, replaced by 21 CFR Part 117, Subpart B. The firm's February 17, 2021, response was deemed insufficient. Martinez Produce & Seafood Inc. must respond within 15 working days, detailing corrective actions, providing revised HACCP plans, verification procedures, product specifications, an affirmative step for imports, and five consecutive days of monitoring records. Failure to comply may lead to regulatory actions, including seizure, injunction, refusal of admission for imported products under Import Alert #16-119, and re-inspection fees.