FDA Inspection 1230475 — Chartwell Pharmaceuticals Congers, LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Congers, LLC on April 8, 2024 in Congers, 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
- April 8, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Congers, NY (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6830 | 21 CFR 314.80(c)(2) | Interval |
| 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 |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |