FDA WARNING_LETTER - Mommy Gina Tuna Resources (MGTR), Inc - July 24, 2013

The FDA issued a Warning Letter to Mommy Gina Tuna Resources (MGTR), Inc. following a review of their Hazard Analysis and Critical Control Points (HACCP) plan for fish and fishery products imported into the United States. The review, based on documents submitted on July 24, 2013, revealed serious deviations from the seafood HACCP regulation (21 CFR Part 123), rendering their frozen vacuum-packaged yellowfin tuna, blue marlin, and mahi-mahi products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and Critical Control Points (CCPs):** The HACCP plan failed to list necessary CCPs for controlling scombrotoxin (histamine) formation during fish transport from port to plant and during all storage periods. 2. **Inadequate Critical Limits:** The critical limit for sensory examination at the "Inspection & Receipt of Fish at Fish Port, CCP 1a" was insufficient. It allowed for up to 3 decomposed fish in a 118-fish sample, but the firm receives smaller lots. FDA recommends sensory evaluation on all fish in lots under 118 fish, with specific limits for decomposition based on sample size. 3. **Inadequate Monitoring Procedures and Frequencies:** Monitoring procedures for scombrotoxin formation and pathogen growth at the "Process