FDA Inspection 823212 — Chartwell Pharmaceuticals Carmel LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Carmel LLC on March 25, 2013 in Carmel, 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
- March 25, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carmel, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |