FDA WARNING_LETTER - Neptunus Seafood B.V. - October 23, 2019

The FDA conducted an inspection of Neptunus Seafood B.V. in the Netherlands on October 22-23, 2019, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. The firm's responses, including a revised HACCP plan for refrigerated pickled herring products, were deemed inadequate. Consequently, the firm's ready-to-eat refrigerated pickled herring products are considered adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. Key deviations include the failure to establish adequate critical limits in the HACCP plan to control scombrotoxin formation and pathogen growth/toxin formation (21 CFR 123.6(c)(3)), inadequate monitoring procedures and frequencies for critical control points (21 CFR 123.6(c)(4)), and inappropriate corrective action plans that do not ensure violative products are prevented from entering commerce or that the cause of deviation is corrected (21 CFR 123.7(b)). The FDA requires a written response 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 of imported products, including detention without physical examination (DWPE) under Import Alert #16-120, and the assessment of re-inspection fees.