Great American Deli – FDA Warning Letter, Mar 3, 2011

The FDA issued a Warning Letter to The H.T. Hackney Company following an inspection of their Ooltewah, Tennessee seafood processing facility from February 28 to March 3, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR 110). Consequently, the firm's Tuna Salad sandwich product, and other sandwich products, were deemed adulterated due to insanitary conditions.

Key violations included the firm's HACCP plan for Modified Atmosphere Packaged Sandwiches failing to list scombrotoxin (histamine) formation as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)). Additionally, the corrective action plan for metal detection at a critical control point was deemed inappropriate, as it did not adequately address equipment as a potential source of metal inclusion (21 CFR 123.7(b)). CGMP violations involved inadequate plant construction and maintenance, with observations of condensate dripping over production lines, peeling flooring, and paint chips, failing to prevent contamination (21 CFR 110.20(b)(4)).

Further, environmental samples revealed Listeria monocytogenes, a human pathogen, in a footbath at the production room entrance, which also had an iodine concentration below the firm's specified range. The firm's March 21, 2011, response was acknowledged but found inadequate for the metal detection issue. The company must promptly correct all violations and respond within 15 working days with detailed corrective actions and supporting documentation to avoid potential legal action, including seizure or injunction.