FDA WARNING_LETTER - 5000 Years Food, Inc. - February 12, 2015

On January 21-February 12, 2015, an FDA inspection of 5000 Years Food, Inc. revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). These violations render products like kimchi, fried anchovy, fried file fish, fried squid, and seasoned pollock adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: - **Lack of Hazard Analysis:** No written hazard analysis for fried file fish, fried squid, fried anchovy, and seasoned dried pollock. - **Missing HACCP Plans:** No HACCP plans for fried anchovy (histamine, pathogenic growth), fried file fish, and fried squid (pathogenic growth from temperature abuse, pathogenic bacteria survival through cooking/pasteurization). - **Inadequate Sanitation Monitoring:** Failure to monitor sanitation conditions and maintain records as per 21 CFR 123.11(b). - **Improper Cleaning/Sanitizing:** Inadequate cleaning procedures for food contact surfaces, including lack of detergent use and improper sanitizer concentration (21 CFR 110.35(d)(5)). - **Unsanitary Facilities:** Plumbing lacking backflow protection, cross-connections with hoses