FDA Inspection 810835 — Chartwell Pharmaceuticals Amityville, LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Amityville, LLC on December 13, 2012 in Amityville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 13, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Amityville, NY (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6736 | 21 CFR 314.80(c)(1)(ii) | Submission of report follow-up |
| 6823 | 21 CFR 314.80(c) | Failure by applicant to report ADE |
| 6827 | 21 CFR 314.80(c)(1)(iv) | Failure to identify report content |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |
| 6842 | 21 CFR 314.80(j) | Failure to maintain records |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |