FDA Inspection 1043109 — Chartwell Pharmaceuticals Carmel LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Carmel LLC on February 28, 2018 in Carmel, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carmel, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |