FDA WARNING_LETTER - P.T. Intimas Surya - September 30, 2011

The FDA issued a Warning Letter to P.T. Intimas Surya on September 12, 2011, following an evaluation of their HACCP plan for frozen smoke-treated, vacuum-packaged tuna and marlin. Serious deviations from the seafood HACCP regulation, 21 CFR Part 123, were identified, rendering their products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations included the firm's failure to list pathogen growth as a food safety hazard in their HACCP plan (21 CFR 123.6(a) and (c)(1)). Corrective actions for scombrotoxin (histamine) at "Receiving" and "Chilling (Chiller Room)" critical control points were deemed inappropriate (21 CFR 123.7(b)). Additional deficiencies involved unclear lot assessment, inadequate internal temperature monitoring, and unverified histamine test kit reliability at "Receiving." Inconsistent monitoring and insufficient corrective actions were noted at "Ice Brine Storage." The "Chilling (Chiller Room)" CCP lacked assurance of meeting conservative temperatures and true continuous monitoring. Labeling issues included missing thawing instructions and the omission of the undeclared allergen hazard (fish proteins) from the hazard analysis. The firm's pre-requisite program also used direct chlorine contact with fish exceeding 10 ppm. P.T. Intimas Surya must respond within thirty working days, detailing specific corrections with supporting documentation. Failure to comply may result in refusal of imported products and detention without physical examination (DWPE) under Import Alert #16-120.