FDA WARNING_LETTER - Eagle New York - October 22, 2013

On October 19 and 22, 2013, the FDA inspected Eagle New York's seafood processing facility in Garfield, NJ, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). The primary violation was the firm's failure to have a written HACCP plan for its herring products, including extra-large herring fillets, roll mop herring, creamed herring, Bismark herring, and thick-cut herring. This omission means the firm failed to control reasonably likely food safety hazards such as scombrotoxin (histamine) formation and pathogen growth and toxin formation, as required by 21 CFR 123.6(a) and (b).

Consequently, the herring products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), having been prepared, packed, or held under insanitary conditions. The FDA requires prompt corrective action to address this violation and prevent recurrence. Failure to comply may result in legal action, including seizure and injunction. The firm must respond in writing within fifteen working days, detailing corrective steps, preventive measures, and supporting documentation. The FDA also noted that re-inspection fees may be assessed