FDA Inspection 1267093 — Glenmark Pharmaceuticals Inc USA
The FDA completed an inspection of Glenmark Pharmaceuticals Inc USA on Jun 17, 2025 in Monroe, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monroe, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |