FDA WARNING_LETTER - Quality Supplement Manufacturing, Inc. - June 13, 2022

The FDA inspected Raymundo Osuna's facility at 300 N. Macarthur Blvd, Oklahoma City, from June 7-13, 2022, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. The company's dietary supplements, including (b)(4) and (b)(4) products, were deemed adulterated under 21 CFR Part 111 (CGMP for dietary supplements).

Key violations include: 1. **Failure to establish product specifications:** No identity and purity specifications for finished dietary supplement batches (21 CFR 111.70(e)). 2. **Inadequate Master Manufacturing Records (MMRs):** MMRs did not match Batch Production Records (BPRs) for manufactured products, failing to ensure uniformity (21 CFR 111.205(a)). 3. **Insufficient finished product verification:** Only one dietary ingredient was verified for strength in multi-ingredient supplements, not meeting specifications for identity, purity, strength, and composition (21 CFR 111.75(c)). 4. **Unscientific test methods:** Relying solely on ingredient input and a single dietary ingredient test is insufficient to verify finished product specifications (21 CFR 111.75(h)(1)). 5. **Quality control failures:** QC personnel failed to reject out-of-specification