Health One Pharmaceuticals Inc – FDA Warning Letter, Oct 5, 2011

On March 28, 2012, the FDA issued a Warning Letter to Health One Pharmaceuticals, Inc. following an inspection from September 14 to October 5, 2011. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products like (b)(4) adulterated.

Key violations include: 1. **Failure to verify dietary ingredient identity (21 CFR 111.75(a)(1)(i)):** The firm relied on inadequate COAs and proposed organoleptic tests, which are insufficient. 2. **Failure to verify finished product specifications (21 CFR 111.75(c)):** Batch records lacked documentation for identity, purity, strength, and composition. 3. **Failure to establish in-process specifications (21 CFR 111.70(c)(1)):** No specifications for capsule weight checks were established. 4. **Inadequate quality control operations (21 CFR 111.123(a)(1), (2), 111.140(b)(2)):** QC failed to review/approve MMRs and batch records, and lacked proper documentation. 5. **Deficient Master Manufacturing Records (MMRs) (21 CFR 111.205(b)(1),