FDA Inspection 876516 — Berdy & Malhotra PC
The FDA completed an inspection of Berdy & Malhotra PC on Apr 25, 2014 in Saint Louis, MO. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 25, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Saint Louis, MO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14512 | 21 CFR 812.2(c) | Needs IDE; not a legally marketed device |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |