FDA Inspection 1120123 — Andrew A. Nierenberg, M.D.
The FDA completed an inspection of Andrew A. Nierenberg, M.D. on February 21, 2020 in Boston, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Boston, MA (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |