FDA Inspection 1144202 — D'Alessandro, Anthony M.
The FDA completed an inspection of D'Alessandro, Anthony M. on June 18, 2021 in Madison, WI. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 18, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Madison, WI (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14508 | 21 CFR 812.140(a)(4) | Investigator record of protocol deviations inadequate |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2985 | 21 CFR 812.140(a)(3)(ii) | Investigator records of relevant observations inadequate |