FDA Inspection 799550 — Chartwell Pharmaceuticals Congers, LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Congers, LLC on September 19, 2012 in Congers, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Congers, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |