FDA WARNING_LETTER - Allied Food Products Inc - March 09, 2020

The FDA inspected an acidified and dry food mix manufacturing facility in Linden, NJ, from February 12 to March 9, 2020, following New York State testing that identified unregistered acidified food products. The inspection revealed serious deviations from Emergency Permit Control (21 CFR 108) and Acidified Foods (21 CFR 114) regulations, leading to products being deemed adulterated under Section 402(a)(4) of the FD&C Act. Key violations included the failure to file scheduled processes for numerous acidified products (21 CFR 108.25(c)(2)), inadequate processing to destroy microorganisms (21 CFR 114.80(a)(1)), and lack of supervision by appropriately trained personnel (21 CFR 114.10). Additionally, the firm failed to test container integrity (21 CFR 114.80(a)(4)) and maintain adequate finished product examination records (21 CFR 114.100(a)). The firm's March 24, 2020, response to the FDA-483 was largely deemed inadequate, with issues noted in provided formulae and lack of completed records. The FDA requires prompt corrective action within fifteen working days, including detailed documentation, to prevent recurrence. Failure to comply may result in regulatory actions such as seizure or injunction, and re-inspection fees may be assessed. The firm is also reminded of its obligations under 21 CFR 117 (CGMP and PC rule).