FDA WARNING_LETTER - Import Food Wholesale - November 24, 2010

The FDA inspected Lin Tep's seafood processing facility in St. Paul, Minnesota, from November 18-24, 2010, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). A significant violation was the firm's failure to conduct a hazard analysis for smoked uneviscerated fish to control Clostridium botulinum, as required by 21 CFR 123.6(a). This renders the firm's smoked uneviscerated fish adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. The letter emphasizes that a proper hazard analysis would prevent the acceptance of inherently unsafe uneviscerated large fish. Additionally, the facility failed to register with the FDA, a requirement under 21 U.S.C. § 350d and 21 CFR Part 1, Subpart H, constituting a prohibited act under 21 U.S.C. § 331(dd). The FDA requested the facility register within 15 working days. The firm must correct these violations promptly, conduct necessary hazard analyses, and implement HACCP plans. A written response detailing corrective actions, including supporting documentation, is required within 15 working days. Failure to comply may result in further actions, such as product seizure or an injunction against the firm's operations.