FDA WARNING_LETTER - Hijos De Carlos Albo S.L. - December 02, 2011

On December 1-2, 2011, the FDA inspected Hijos De Carlos Albo S.L., a seafood manufacturing facility in Vigo, Spain, and found serious deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR 123). Although the firm's initial response to the FDA-483 satisfactorily addressed the listed deviations, a further evaluation revealed inadequate implementation of the Seafood HACCP regulation.

The primary violation identified was the firm's HACCP plan for various fresh whole fish, including scombrotoxin-forming species processed into canned food, which failed to list scombrotoxin formation and *Staphylococcus aureus* toxin formation as reasonably likely food safety hazards. Processing steps like thawing, storage, heading, cutting, and cooling, conducted prior to retort operation, can lead to excessive histamine development if uncontrolled. Manual cleaning of fish before canning can also lead to *Staphylococcus aureus* contamination, growth, and toxin formation if not properly controlled. Therefore, the HACCP plan for canned scombrotoxin-forming fish species must include histamine formation and *Staphylococcus aureus* growth and toxin formation hazards, along with necessary critical controls.

Failure to implement a compliant HACCP plan renders fishery products adulterated under section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. The firm's canned tuna products are considered adulterated.

Hijos De Carlos Albo