FDA Inspection 1011507 — Chartwell Pharmaceuticals Amityville, LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Amityville, LLC on May 5, 2017 in Amityville, 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
- May 5, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amityville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 1852 | 21 CFR 211.94(a) | Reactive/Additive/Absorptive Containers/Closures |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |