FDA WARNING_LETTER - PT. SIG ASIA - December 03, 2019

On July 12, 2019, the FDA requested and reviewed the firm's "HACCP FROZEN TUNA" plan and associated monitoring records for tuna products imported into the U.S. The review revealed serious deviations from the seafood Hazard Analysis Critical Control Point (HACCP) regulation, 21 CFR Part 123, rendering the firm's tuna products adulterated under 21 U.S.C. § 342(a)(4). Significant deviations include the failure to list pathogen growth and toxin formation as a reasonably likely food safety hazard in raw ready-to-eat products (21 CFR 123.6(a) and (c)(1)). The HACCP plan also lacks critical control points for unrefrigerated processing to control scombrotoxin (histamine) formation (21 CFR 123.6(a) and (c)(2)). Furthermore, the critical limits listed in the plan for scombrotoxin and Clostridium botulinum toxin formation are inadequate (21 CFR 123.6(c)(3)), and the corrective action plans for frozen tuna are not appropriate (21 CFR 123.7(b)). The firm must respond within fifteen working days, outlining specific corrective steps, including a revised HACCP plan and five consecutive days of monitoring records. Failure to adequately respond may result in refusal of admission for imported products, including Detention Without Physical Examination (DWPE) and listing on Import Alert #16-120.