FDA WARNING_LETTER - Pavlos Trifonidis S.A - March 15, 2019

The FDA issued a Warning Letter to Pavlos Trifonidis S.A. following an inspection of their seafood processing facility in Greece from March 14-15, 2019. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123), rendering their tuna "Lakerda" and canned salted anchovies adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. The firm's submitted responses, including revised HACCP plans, were deemed inadequate. Key deficiencies included a failure to list adequate critical limits in HACCP plans for controlling hazards like scombrotoxin, Staphylococcus aureus, and Clostridium botulinum (21 CFR 123.6(c)(3)). The firm also failed to conduct a proper hazard analysis to identify critical control points (21 CFR 123.6(a) and (c)(2)) and lacked adequate monitoring procedures and frequencies for critical control points (21 CFR 123.6(c)(4)). Furthermore, the corrective actions described in their HACCP plans were inappropriate, failing to ensure adulterated products would not enter commerce (21 CFR 123.7(b)). The firm's HACCP plans also listed inadequate verification procedures for controlling Clostridium botulinum in both salted anchovies and tuna. Pavlos Trifonidis S.A. must respond within 15 working days, detailing corrective steps, providing revised HACCP plans, and five consecutive days of monitoring records. Failure to comply could result in refusal of admission for imported products, placement on Detention Without Physical Examination (DWPE), and re-inspection fees. The firm is responsible for ensuring full compliance with all applicable regulations.