FDA WARNING_LETTER - Nara Company Ltd. - September 07, 2022

On February 7, 2023, the FDA issued a Warning Letter to Nara Company Ltd. following a Foreign Regulatory Assessment (FRRA) on September 7, 2022. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their fish fillet products adulterated under 21 U.S.C. § 342(a)(4).

The firm's October 7, 2022, response, including a revised HACCP plan, was deemed inadequate. Specific violations include: 1. Failure to list reasonably likely food safety hazards (pathogenic bacteria growth and toxin formation, metal inclusion) in the HACCP plan, violating 21 CFR 123.6(a) and (c)(1). 2. Inadequate critical limits in the HACCP plan (September 19, 2022, version) to control identified hazards, violating 21 CFR 123.3(c)(3). Examples of inadequate critical limits cited were harvest vessel records/histamine testing, sensory examination, internal temperature measurements, and transit control.

Nara Company Ltd. must respond within fifteen working days, outlining corrective actions, including a revised HACCP plan, five consecutive days of monitoring records, and any additional compliance assurance. Failure to respond adequately may result in refusal