FDA Inspection 817330 — Strides Pharma, Inc.
The FDA completed an inspection of Strides Pharma, Inc. on Feb 19, 2013 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
- Feb 19, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chestnut Ridge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |