FDA Inspection 1028855 — Ronald F. Budzik Jr., MD
The FDA completed an inspection of Ronald F. Budzik Jr., MD on Oct 17, 2017 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: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 17, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Columbus, OH (United States)
Additional details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |