FDA Inspection 1074669 — Thomas A. Schaum, M.D
The FDA completed an inspection of Thomas A. Schaum, M.D on Dec 14, 2018 in Oldenburg In Holstein. 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
- Dec 14, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Oldenburg In Holstein (Germany)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |