FDA Inspection 1226661 — Lynn Malec, M.D.
The FDA completed an inspection of Lynn Malec, M.D. on Jan 8, 2024 in Milwaukee, WI. 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 8, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Milwaukee, WI (United States)
Additional details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |