FDA WARNING_LETTER - Amor Nino Foods, Inc. - January 24, 2023

On June 26, 2023, the FDA issued a Warning Letter to Mr. Nino regarding serious violations at their seafood processing facility at 1928 Homerule Street, Honolulu, HI, following an inspection from January 11 to January 24, 2023. The facility was found in violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

Specifically, the firm's ready-to-eat Hawaiian Style Aku (Skipjack Tuna) Sticks were deemed adulterated due to preparation, packing, or holding under insanitary conditions. The primary violations include an inadequate HACCP plan for Hawaiian Style Skipjack Tuna Sticks, with critical limits insufficient to control Scombrotoxin formation and pathogen growth (specifically S. aureus toxin formation) at the drying and ingredient measurement critical control points. The firm lacked a validated study to support these critical limits and had stopped analytical testing verification procedures in July 2019.

Additionally, the firm failed to implement monitoring procedures listed in their HACCP plan for Scombrotoxin and pathogen control. For instance, continuous temperature monitoring devices were not used at the chill storage critical control point, and monitoring procedures for drying temperature were not implemented, with no records maintained. These monitoring