FDA WARNING_LETTER - Amor Nino Foods Inc - March 16, 2012

On May 11, 2012, the FDA issued a Warning Letter to Amor Nino Foods Inc. following an inspection from February 28 to March 16, 2012, at their Honolulu, Hawaii facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their refrigerated ready-to-eat Dried Aku products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan:** The firm's HACCP plan for Dried Aku failed to list pathogen growth and toxin formation (specifically *Staphylococcus aureus*) as a reasonably likely food safety hazard during drying, in violation of 21 CFR 123.6(a) and (c)(1). While histamine formation was listed, the plan was incomplete. 2. **Insufficient Sanitation Monitoring:** The firm did not monitor sanitation conditions and practices with sufficient frequency (21 CFR 123.11(b)). Observed deficiencies included: * Dirty plastic bins with significant grime and residue build-up used for tuna storage. * An employee touching unsanitary surfaces (door, door handle, door jam) and then hand-packing finished ready-to-eat Dried Aku without washing hands or using gloves, indicating