FDA WARNING_LETTER - StarKist Company - November 04, 2010

On March 1, 2011, the FDA issued a Warning Letter to StarKist Company following an inspection of their American Samoa facility from November 1-4, 2010. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and deviations from Thermally Processed Low-Acid Foods in Hermetically Sealed Containers regulations (21 CFR 113). These violations render their canned and pouched tuna products adulterated.

Key HACCP violations include: 1. Failure to list *Staphylococcus aureus* growth and toxin formation as a food safety hazard in the tuna HACCP plan, particularly concerning thawing and holding of pre-cooked loins at elevated temperatures. 2. Failure to list critical control points (CCPs) for post-thawing processing steps to control scombrotoxin formation and for cleaning, packing, and retorting steps to control *Staphylococcus aureus* growth. 3. Inadequate monitoring procedures for scombrotoxin testing, specifically concerning sample collection methods. 4. Failure to implement monitoring frequencies as listed in the HACCP plan, particularly regarding lot definition at the Receiving CCP. 5. Inadequate verification of staff's ability to detect decomposition in raw tuna. 6. Failure to take appropriate corrective action when critical limits were exceeded for thaw time, specifically concerning scombrotoxin formation.