FDA Inspection 1046395 — Sergio D. Bergese
The FDA completed an inspection of Sergio D. Bergese on Mar 30, 2018 in Columbus, OH. 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
- Mar 30, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Columbus, OH (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7527 | 21 CFR 312.62(a) | Unused drug disposition (investigator) |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |