FDA WARNING_LETTER - North Fish Co Ltd - June 21, 2012

On November 21, 2012, the FDA issued a Warning Letter to North Fish Co., Ltd. following an inspection from June 19-21, 2012, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The FDA found the company's salted herring, dried salted white fish, and refrigerated cold smoked mackerel to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: - **Inadequate Hazard Analysis and HACCP Plans (21 CFR 123.6(a) and (c)(1)):** Failure to list Clostridium botulinum growth and toxin formation as a hazard in HACCP plans for various products, especially concerning thawing and processing of fish at ambient temperatures or when only partially thawed. Also, failure to list parasites as a hazard for fresh, raw products. - **Missing Critical Control Points (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for certain products did not list a critical control point for controlling pathogen growth and scombrotoxin formation during processing steps. - **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** HACCP plans lacked specific temperature critical limits for controlling Clostridium botulin