FDA Inspection 1079804 — Chartwell Pharmaceuticals Amityville, LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Amityville, LLC on February 13, 2019 in Amityville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 13, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amityville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4316 | 21 CFR 211.84(d)(3) | Testing Containers & Closures Conformity with Specs |