FDA Inspection 1239755 — Shalini Iyengar, MBBS
The FDA completed an inspection of Shalini Iyengar, MBBS on May 24, 2024 in Hexham. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 24, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Hexham (United Kingdom)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |