FDA Inspection 1215105 — Scitus Pharma Services Pvt Ltd
The FDA completed an inspection of Scitus Pharma Services Pvt Ltd on August 18, 2023 in Chennai. 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
- August 18, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Chennai (India)
Additional Details
Clinical BA/BE
Citations
| ID | CFR | Description |
|---|---|---|
| 7664 | 21 CFR 50.20 | Circumstances of obtaining consent |