Alfa International Seafood, Inc. & Gamma Seafood Corporation – FDA Warning Letter, Sep 12, 2007

The FDA inspected Alfa International Seafood, Inc. (AIS) and Gamma Seafood Corporation (GSC) from August to September 2007, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render their seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: - **Inadequate HACCP Plans (21 CFR 123.6(a) and (c)(2)):** AIS and GSC's HACCP plans for various fresh fish products, especially reduced oxygen packaged items, failed to list critical control points (CCPs) for *C. botulinum* growth and toxin formation related to Time Temperature Indicators (TTIs). - **Insufficient Critical Limits (21 CFR 123.6(c)(3)):** Critical limits for "Product Storage" in several HACCP plans were inadequate to control histamine (scombrotoxin) formation and *C. botulinum* growth, particularly for reduced oxygen packaged products. - **Failure to Take Appropriate Corrective Action (21 CFR 123.7(a)):** The firm failed to take corrective action when vacuum-packed blue marlin deviated from critical limits, accepting and distributing product with color