1277530
Chartwell Pharmaceuticals Congers, LLC — FEI 3008897678
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 18, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Congers, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3609 | 21 CFR 211.160(b)(2) | In-process sample representation/identification |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4321 | 21 CFR 211.101(b) | Identification of new containers |