FDA Inspection 1308284 — Nicolas J. Mouawad, MD
The FDA completed an inspection of Nicolas J. Mouawad, MD on Mar 20, 2026 in Bay City, MI. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 20, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Bay City, MI (United States)
Additional details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 2983 | 21 CFR 812.140(a)(2)(iii) | Investigator records of disposition of devices inadequate |
| 3063 | 21 CFR 812.140(a)(3)(iii) | Investigator records of exposure to device inadequate |