FDA Inspection 849682 — Alexander G Digenis MD
The FDA completed an inspection of Alexander G Digenis MD on September 5, 2013 in Louisville, KY. 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
- September 5, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Louisville, KY (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |