FDA WARNING_LETTER - Grupo Alimentario Del Atlantico Sa "Gralco Sa" - August 10, 2009

On August 6-10, 2009, the FDA inspected Grupo Alimentario Del Atlantico S.A.'s seafood processing facility in Barranquilla, Columbia, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, their canned and vacuum-packaged frozen tuna products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: * **Inadequate Hazard Analysis:** The HACCP plan for "Frozen tuna loins and canned tuna" fails to list Staphylococcus aureus toxin development as a reasonably likely food safety hazard after the precook operation, given up to 10 hours of handling and holding. This also poses an additional risk for histamine development. * **Insufficient Corrective Actions:** The corrective action plan for foreign contaminants (metal fragments) at the "Skinning/Cleaning" critical control point is inadequate. Re-testing suspected product and holding it will not prevent distribution of adulterated products, nor does the plan address the source of fragments or final product disposition.

Additional comments on the HACCP plan include: * The receiving critical control point should include (b)(4) subsamples for histamine testing, not (b)(4). * The critical limit for histamine at