FDA Inspection 935584 — Chartwell Pharmaceuticals Amityville, LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Amityville, LLC on July 20, 2015 in Amityville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amityville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |