ABC Food Corp – FDA Warning Letter, Apr 7, 2026

The FDA issued a warning letter to ABC Food Corp following an inspection of its Boston, MA, facility conducted between March 17 and April 7, 2026. The inspection identified serious violations of the Hazard Analysis and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Consequently, the FDA determined that the firm’s ready-to-eat (RTE) rice noodles and tofu were produced under insanitary conditions, rendering them adulterated under the Federal Food, Drug, and Cosmetic Act. Significant violations included the failure to conduct a hazard analysis for biological risks such as Clostridium botulinum and Bacillus cereus, particularly regarding time-temperature abuse during cooling and storage. Investigators also observed inadequate lethality treatments, lack of environmental pathogen controls, and poor sanitation practices. Specific examples involved employees failing to wash hands after touching non-sanitized surfaces and condensate from overhead pipes dripping onto food-contact surfaces. Additionally, the company lacked preventive controls for undeclared allergens and failed to maintain facility floors in good repair. While the company submitted an initial response in April 2026, the FDA found it lacked substantive evidence of completed corrective actions. ABC Food Corp is required to respond within 15 working days with a detailed plan and documentation illustrating how they will rectify these violations and prevent their recurrence. Failure to comply may lead to legal actions, including product seizure or injunctions.