FDA WARNING_LETTER - El Abuelito Cheese, Inc. - February 06, 2020

An FDA inspection conducted from January 14 to February 6, 2020, at a facility manufacturing ready-to-eat (RTE) cheese products in Paterson, New Jersey, revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The firm failed to conduct a hazard analysis for RTE foods, specifically for environmental pathogens like Listeria monocytogenes, as required by 21 CFR 117.130(a). Additionally, the facility did not establish and implement preventive controls, such as sanitation controls, to minimize or prevent identified hazards (21 CFR 117.135(a)(1)). A significant deficiency was the absence of a written food safety plan, a repeat observation from a previous May 2019 inspection, which is required by 21 CFR § 117.126(a)(1) and must include hazard analysis, preventive controls, a supply-chain program, a recall plan, and procedures for monitoring, corrective actions, and verification. Environmental swabs tested positive for non-pathogenic Listeria species, indicating conditions conducive to pathogenic Listeria monocytogenes, yet the firm did not conduct environmental monitoring for Listeria spp. The firm also lacked monitoring for sanitizer solution concentrations. The FDA requires a written response within fifteen working days detailing corrective actions, including documentation like revised procedures and test results. Failure to comply may lead to regulatory actions such as seizure or injunction, and the firm may be subject to re-inspection fees.