FDA WARNING_LETTER - Acquired Holding Inc - November 20, 2009

On October 23-November 20, 2009, the FDA inspected Acquired Holding, Inc.'s seafood processing facility in Buckner, KY, finding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their thawed vacuum-packed tilapia, pasteurized canned crabmeat, and Lemon Pepper catfish products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: * **Lack of HACCP plans:** No HACCP plan for thawed vacuum-packed tilapia to control *Clostridium botulinum* growth, or for Lemon Pepper Catfish to control undeclared allergenic substances (FD&C Yellow #5). * **Inadequate critical limits:** The HACCP plan for "CRABMEAT (FRESH)" lists a critical temperature limit of "45°F Maximum" for receiving and storage, which is insufficient to control pathogen growth and toxin formation; FDA recommends 40°F or below. * **Insufficient monitoring procedures:** The "CRABMEAT (FRESH)" HACCP plan's monitoring procedures for "biological temperature" are inadequate. Taking temperature of "every shipment" at receiving doesn't ensure continuous proper transit temperatures. Checking cooler temperatures "once a day at start-up" is insufficient for continuous monitoring,