FDA Inspection 1215417 — Lewis, Karl D. MD
The FDA completed an inspection of Lewis, Karl D. MD on August 7, 2023 in Aurora, 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 7, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Aurora, CO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7378 | 21 CFR 50.27(a) | Copy of consent form not provided |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |