FDA Inspection 1169876 — Glenmark Pharmaceuticals Inc USA
The FDA completed an inspection of Glenmark Pharmaceuticals Inc USA on May 19, 2022 in Monroe, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 19, 2022
- Fiscal Year
- 2022
- 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 |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |