FDA Inspection 1005489 — Stefan Rath, MD
The FDA completed an inspection of Stefan Rath, MD on Mar 17, 2017 in Deggendorf. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 17, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Deggendorf (Germany)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 7013 | 21 CFR 812.110(d) | Inadequate financial disclosure by investigator |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |