Friz-it Cold Storage, Inc. – FDA Warning Letter, Jul 13, 2010

The FDA inspected Friz-it Cold Storage, Inc. from July 7-13, 2010, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These deficiencies render the firm's scombroid fish, canned pasteurized crab meat, and fresh ready-to-eat crab meat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations included the failure to implement monitoring procedures and frequencies as outlined in their HACCP plans for histamine-producing fish, specifically regarding continuous monitoring at storage critical control points and daily thermometer accuracy checks, as required by 21 CFR 123.6(b) and (c)(4). Furthermore, the corrective actions described in the HACCP plan for "Fresh fish with the potential hazard of histamines" were inadequate, failing to properly address problem correction or the handling of affected product, and not ensuring product safety through 10% lot analysis, violating 21 CFR 123.7(h). The FDA requires a written response within fifteen working days, detailing specific corrective actions and providing supporting documentation. Failure to promptly correct these violations may lead to further action, including product seizure or an injunction against the firm's operations.