FDA WARNING_LETTER - Alimentos Prosalud, Sardimar - October 23, 2012

The FDA inspected Alimentos Prosalud Sardimar in Puntarenas, Costa Rica, on October 22-23, 2012, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Consequently, the firm's canned sardines and tuna products were deemed adulterated. The primary deficiencies included the firm's HACCP plans failing to list critical control points (CCPs) from thawing to the final retort operation for canned sardines and tuna, which could lead to histamine and pathogen growth (21 CFR 123.6(a) and (c)(2)). Additionally, the HACCP plans did not identify undeclared allergens as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)). The firm's November 13, 2012, response to the FDA-483 was deemed inadequate, providing incomplete revised HACCP plans and not fully addressing all concerns. Alimentos Prosalud Sardimar must respond within 15 working days, outlining specific corrections, providing complete revised HACCP plans, at least five days of monitoring records, and verification records. Failure to adequately respond could result in further action, including refusal of admission for imported products into the U.S. through detention without physical examination (DWPE) and the assessment of re-inspection fees. The FDA also recommended setting histamine critical limits at "50ppm for individual samples, adjusted for composite samples.