FDA Inspection 1031352 — Matson, Mark A., MD, Clinical Investigator, Prism Research
The FDA completed an inspection of Matson, Mark A., MD, Clinical Investigator, Prism Research on Nov 15, 2017 in Saint Paul, MN. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 15, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Saint Paul, MN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |