FDA WARNING_LETTER - A. Tarantino and Sons, Inc. - April 08, 2008

An FDA inspection of A. Tarantino and Sons, Inc.'s seafood processing facility in San Francisco on April 3 and 8, 2008, revealed 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, the firm's refrigerated canned wild crabmeat, vacuum packed smoked salmon, vacuum packed smoked trout, and histamine-forming fishery products were deemed adulterated. Key deficiencies included the absence of a HACCP plan for reduced oxygen packaged seafood products to control pathogen growth and toxin formation, particularly Clostridium botulinum, as required by 21 CFR 123.6(a) and (b). Additionally, the existing HACCP plan for histamine-forming products had inadequate monitoring procedures and frequency at the refrigerated storage critical control point (21 CFR 123.6(c)(4)), with intermittent temperature checks being insufficient. The firm's corrective action plans for histamine formation were also found inappropriate, failing to address the root cause of deviations (21 CFR 123.7(b)). The FDA requires a written response within fifteen working days, detailing specific corrective actions and providing supporting documentation. Failure to comply may result in product seizure or an injunction against the firm's operations.