FDA Inspection 1181090 — Chartwell Pharmaceuticals Carmel LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Carmel LLC on October 6, 2022 in Carmel, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 6, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carmel, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |