FDA WARNING_LETTER - Golub Corporation - February 27, 2008

On February 26 and 27, 2008, the FDA inspected Golub Corporation's seafood processing facility in Rotterdam, New York, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render their refrigerated ready-to-eat seafood salad and tuna salad adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan for refrigerated ready-to-eat seafood and tuna salad lists a critical limit at the receiving critical control point that is insufficient to control pathogen growth, toxin production, and scombrotoxin formation in tuna salad. The plan's various critical limit and monitoring procedure options are not equivalent or interchangeable for all shipping situations, particularly for extended transport times where continuous temperature monitoring or cooling media adequacy should be specified. 2. **Failure to Implement Record Keeping:** The firm failed to record monitoring observations at the receiving critical control point for seafood and tuna salad shipments between January 3, 2007, and February 26, 2008, despite receiving approximately 1,000 shipments of seafood salad and 1,000 shipments of tuna salad. 3.