FDA WARNING_LETTER - Agustson A/S - March 05, 2024

The FDA inspected Lundahl Nielsens Vej 2, Denmark, from March 4-5, 2024, and found serious deviations from the Emergency Permit Control (21 CFR Part 108) and Acidified Foods (21 CFR Part 114) regulations. The firm's response dated March 25, 2024, was deemed inadequate. Key violations include failure to process acidified foods in conformity with filed scheduled processes (21 CFR 108.25(c)(3)(i)), failure to file scheduled processes before packing new products (21 CFR 108.25(c)(2)), and failure to assure finished product equilibrium pH of less than 4.6 (21 CFR 114.80(a)(1)). Specifically, Seaweed Cavi-art Black was exported without adhering to filed processes or monitoring critical parameters, and the firm relied on supplier COAs without internal verification. Additional violations include not marking containers with identifying codes (21 CFR 114.80(b)) and lacking personnel trained in critical factors for LACF products (21 CFR 114.10). These violations render the firm's acidified food products adulterated under section 402(a)(4) of the Act. The FDA requires a written response within fifteen working days detailing corrective actions and documentation. Failure to comply may result in refusal of admission and detention without physical examination (DWPE) under section 801(a) of the Act, potentially through Import Alerts 99-37 and 99-38. The firm also received a separate Warning Letter for seafood HACCP violations at another facility.