FDA WARNING_LETTER - Fanta Seafoods - January 27, 2023

The FDA issued a warning letter to Duane Faerber of a seafood processing facility located at Coldingen Industrial Estate, Georgetown, Guyana, following an inspection conducted on January 26-27, 2023. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation under Title 21, CFR Part 123. Key issues included the absence of a proper HACCP plan tailored to specific fish and fishery products, inadequate identification of food safety hazards such as allergens, sulfites, scombrotoxin formation, and pathogen growth, and insufficient corrective actions and sanitation monitoring.

The facility"s HACCP plan failed to differentiate between products with varying food safety hazards and processing methods, grouping incompatible species and processes. Specific hazards not addressed included Clostridium botulinum, Staphylococcus aureus, Listeria monocytogenes, and Salmonella. Additionally, the plan did not adequately address the risk of histamine formation in mackerel species or sulfite hazards in shrimp.

The FDA requires the facility to develop and implement a HACCP plan that accurately identifies and controls all significant food safety hazards, ensuring corrective actions prevent unsafe products from entering commerce. The facility must also enhance sanitation monitoring to comply with current good manufacturing practices. The FDA expects a written response detailing corrective actions to address these violations. Failure to comply may result in regulatory actions, including product seizure or injunction.