FDA WARNING_LETTER - Burnette Foods, Inc. - December 04, 2013

The FDA conducted an inspection of Burnette Foods, Inc.'s acidified food manufacturing facility in Hartford, Michigan, from November 26 to December 4, 2013. The inspection revealed serious violations of 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods), leading to a determination that the firm's acidified food products, including hummus, are adulterated under 21 U.S.C. § 342(a)(4). Significant violations included the firm's failure to process acidified foods in conformity with its filed scheduled processes, as required by 21 CFR 108.25(c)(2). Specifically, hummus was manufactured at incorrect temperatures, and critical factors like initial temperature, hot fill/hold times, and product inversion were not consistently met. Additionally, the firm failed to fully reprocess, thermally reprocess, or set aside for evaluation portions of food that deviated from a scheduled process, as mandated by 21 CFR 114.89. Hummus manufactured on November 18, 2013, deviated from its scheduled process, lacked deviation records, and was subsequently shipped. The firm's December 12, 2013, response to the FDA 483 was deemed inadequate due to the absence of revised processing records and batch sheets. A subsequent revised filing for hummus was also returned for additional information. Burnette Foods, Inc. must take prompt action to correct these violations. Failure to do so may result in regulatory actions such as seizure, injunction, application of emergency permit provisions, and assessment of re-inspection fees. A written response detailing specific corrective actions and timelines is required within 15 working days.