FDA Inspection 603167 — Strides Pharma, Inc.
The FDA completed an inspection of Strides Pharma, Inc. on Aug 7, 2009 in Chestnut Ridge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 7, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chestnut Ridge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |