FDA WARNING_LETTER - Songkla Canning Public Company Limited - December 09, 2009

An FDA inspection of Songkla Canning Public Company Limited's seafood processing facility in Thailand, conducted December 7-9, 2009, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Consequently, the firm's canned tuna, pouch packed tuna, and pasteurized crab meat are deemed adulterated under 21 U.S.C. § 342(a)(4). Key deficiencies include the failure to conduct a comprehensive hazard analysis and list all critical control points for scombrotoxin formation in tuna processing (21 CFR 123.6(a), (c)(2)), with SOPs/SSOPs being inadequate substitutes. The firm also listed inadequate critical limits in its HACCP plans (21 CFR 123.6(c)(3)), such as relying solely on histamine testing for tuna at receiving and lacking specific time/temperature limits for pasteurization of crab meat. Furthermore, monitoring procedures and frequencies were insufficient (21 CFR 123.6(c)(4)), with non-continuous pasteurization monitoring and inadequate 24/7 refrigerated storage temperature checks. Concerns from a prior FDA Form 483 regarding low-acid canned food (LACF) operations, specifically the visibility of bleeders to retort operators, also require attention. The company must respond within 30 working days with corrective actions, including revised HACCP plans and monitoring records. Failure to comply may result in refusal of admission for imported products into the U.S., including Detention Without Physical Examination (DWPE) under Import Alert #16-120.