FDA Inspection 1193806 — Chartwell Pharmaceuticals Amityville, LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Amityville, LLC on December 21, 2022 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: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 21, 2022
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Amityville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |