FDA Inspection 858736 — Anne E. Burke, MD
The FDA completed an inspection of Anne E. Burke, MD on December 13, 2013 in Baltimore, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 13, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Baltimore, MD (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |