FDA WARNING_LETTER - High Quality Organics, Inc. - January 04, 2024

The FDA inspected a ready-to-eat (RTE) spice facility at 12101 Moya Blvd., Reno, NV, from November 27-December 07, 2023, and January 03-04, 2024, for processing/packaging of RTE organic herbs, spices, dried fruit/peels, and dried vegetables. The inspection revealed serious violations of the CGMP & PC rule (21 CFR Part 117), leading to the determination that products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: 1. **Supply-Chain Program (21 CFR 117.405(a)(1), 117.410(c)):** The firm failed to implement a risk-based supply-chain program for raw materials with hazards requiring supply-chain-applied controls. Specifically, the program does not assure that third-party treatment of untreated products (e.g., caraway seeds, lemon peel) adequately controls vegetative pathogens like Salmonella. The firm did not verify treatment parameters, review validation studies, or maintain documentation of validated processes for a Salmonella reduction. Previous FDA inspections (2020, 2021) cited similar issues, and the firm's promised corrective actions, including a "VENDOR MANAGEMENT PROGRAM"