FDA Inspection 898070 — Strides Pharma Science Limited
The FDA completed an inspection of Strides Pharma Science Limited on August 26, 2014 in Bangalore. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 26, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bangalore (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |