FDA WARNING_LETTER - Western Innovations, Inc. - February 21, 2024

The FDA inspected a facility at 4825 Nome Street, Denver, CO, from January 29 to February 21, 2024, and identified significant violations of the Federal Food, Drug, and Cosmetic Act, specifically Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). These violations render the dietary supplements manufactured at the facility adulterated under section 402(g)(1) of the Act.

Key violations include: 1. **Failure to establish component specifications (21 CFR 111.70(b))**: The firm failed to establish identity, purity, strength, composition, and contamination limits for components like silica mineral hydride complex and Acetyl-glutathione used in their Acetyl-glutathione product. Supplier COAs were insufficient or lacked necessary details. 2. **Failure to establish quality control procedures (21 CFR 111.103)**: No written procedures for quality control operations, material review, disposition decisions, or reprocessing approval were established. 3. **Failure to prepare Master Manufacturing Records (MMRs) (21 CFR 111.205(a))**: The provided MMR was not specific to a unique dietary supplement formulation or batch size. 4. **Incomplete Batch Production Records (21 CFR 111.255(b), 21 CFR