FDA WARNING_LETTER - Gordon Food Company, Inc. - March 01, 2012

The FDA conducted an inspection of Gordon Food Company, Inc.'s multiple food storage facility in Memphis, Tennessee, from February 21-23 and March 1, 2012. The inspection revealed serious violations of 21 CFR Part 110, Current Good Manufacturing Practice regulations, leading to food being deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions and confirmed rodent contamination. Significant deviations included failure to exclude pests from food storage areas [21 CFR 110.35(c)], inadequate screening against pests with open exterior doors [21 CFR 110.20(b)(7)], failure to protect food from condensate dripping in the freezer [21 CFR 110.93 and 110.20(b)(4)], and failure to minimize waste as a pest attractant [21 CFR 110.37(f)]. The firm made a verbal commitment to correct deficiencies and submitted a written response to the FDA Form 483, acknowledging cleaning and voluntary destruction of products. However, the FDA requires a written response within fifteen working days detailing specific steps to prevent recurrence, including documentation and a timeframe for planned building renovations. The letter noted these deviations were similar to previous inspections. Failure to promptly correct violations may result in further regulatory action, including product seizure, injunction, and re-inspection fees.