FDA Inspection 1193537 — Anish S. Shah, M.D.
The FDA completed an inspection of Anish S. Shah, M.D. on Dec 16, 2022 in Santa Rosa, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 16, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Santa Rosa, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |