FDA WARNING_LETTER - Etai's Food, Inc. - March 17, 2020

The FDA issued a Warning Letter to a ready-to-eat (RTE) food manufacturing facility in Denver, Colorado, following an inspection from February 12 to March 17, 2020. The facility manufactures RTE products including salads, sandwiches, and burritos. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), rendering the firm's products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Hazard Analysis and Risk-Based Preventive Controls (Subpart C):** Failure to implement environmental monitoring procedures as required by 21 CFR 117.165(b)(3). The firm did not monitor at the stated frequency, had "indeterminate" Listeria spp. results without corrective actions, and lacked a "Master Site List" for sampling. 2. **Supply-Chain Program (Subpart G):** Failure to implement a risk-based supply-chain program for raw materials with identified hazards (e.g., basil and walnuts) as required by 21 CFR 117.405(a)(1). The firm lacked required documentation (supplier approval packets, 3rd party audits, specifications, COCs) from suppliers. This is a recurring issue from previous inspections.