FDA WARNING_LETTER - Gialmar - Produtos Alimentares SA - February 12, 2014

The FDA issued a Warning Letter to Gialmar ? Produtos Alimentares SA following an inspection on February 11-12, 2014, which revealed significant deviations from the United States Food and Drug Administration’s seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Despite the firm submitting a revised HACCP plan, concerns persisted. The primary violations identified were: 1) Failure to have a HACCP plan with adequate critical limits to control scombrotoxin (histamine) formation in sardines, mackerel, and horse mackerel, specifically lacking parameters for onboard vessel handling or sufficient histamine analysis/sensory examination at receiving (21 CFR 123.6(c)(3)). 2) Inadequate monitoring procedures and frequency for critical control points, particularly for sensory examinations (21 CFR 123.6(c)(4)). 3) Inappropriate predetermined corrective action plans for deviations from critical limits, with specific deficiencies noted for temperature and sensory examination deviations (21 CFR 123.7(b)). These failures render the firm's fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Gialmar must respond within 15 working days, detailing corrective actions, providing a revised HACCP plan, and five consecutive days of monitoring records. Failure to comply could result in refusal of admission for imported products, including detention without physical examination, and assessment of re-inspection fees.