FDA WARNING_LETTER - Ya Ya Foods USA, LLC - May 16, 2024

On September 24, 2024, the FDA issued a Warning Letter to Mr. Abbas, following an inspection of their low-acid canned food (LACF) facility in Ogden, UT, from May 13-16, 2024. The inspection identified serious deviations from 21 CFR Part 108 (Emergency Permit Control) and 21 CFR Part 113 (Thermally Processed Low-Acid Foods). These violations render their aseptically processed oat milk products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Failure to identify deviations from scheduled process (21 CFR 113.89):** Multiple instances of sterile seal/barrier temperatures falling below critical parameters (e.g., 250°F) were observed, attributed to steam supply issues during a plant expansion. Corrective actions, including increasing steam supply pressure and cleaning steam line filters, were noted, but their adequacy will be verified. 2. **Inadequate monitoring of steam seals/barriers (21 CFR 113.40(g)(1)(ii)(E)):** Critical factors for aseptic surge tank and homogenizer steam barriers were not continuously monitored or adequately documented in batch records, despite electronic records existing. Staff training and revised procedures were initiated, but implementation records are pending.