FDA Inspection 1205599 — Arthur R. Cabrera, M.D.
The FDA completed an inspection of Arthur R. Cabrera, M.D. on May 16, 2023 in Louisville, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Louisville, CO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14511 | 21 CFR 812.2(b) | Abbreviated requirements / non-significant risk study |
| 6849 | 21 CFR 812.5(a) | Label does not contain required information |
| 7664 | 21 CFR 50.20 | Circumstances of obtaining consent |