FDA WARNING_LETTER - Gadre Marine Export Pvt. Ltd. - August 14, 2013

An FDA inspection of Gadre Marine Export Pvt. Ltd. in Chorwad, Gujarat, India, on August 13-14, 2013, revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Consequently, the firm's vacuum-packaged frozen imitation crab sticks are considered adulterated. The firm's submitted responses, including a revised HACCP plan, were deemed inadequate.

Key violations included: 1) Failure to conduct a proper hazard analysis and list all critical control points (e.g., container sealing, cooling) in the HACCP plan to control post-pasteurization contamination, as required by 21 CFR 123.6(a) and (c)(2). 2) The HACCP plan lacked adequate monitoring procedures and frequencies for critical control points, such as pasteurization temperature and allergen declaration, failing to ensure conformance with critical limits (21 CFR 123.6(c)(4)). 3) Corrective action plans for critical control points like "Receipt of labeling" and "Pasteurization" were inappropriate, not ensuring the cause of deviations would be corrected (21 CFR 123.7(b)).

The FDA requires a written response within 15 working days, detailing specific corrective actions, including a revised HACCP plan and five consecutive days of monitoring records. Failure to comply may result in refusal of admission for imported products, including detention without physical examination (DWPE), and assessment of re-inspection fees. The firm is responsible for ensuring compliance with all applicable regulations, including Seafood HACCP and Good Manufacturing Practice (21 CFR 110).