FDA Inspection 578254 — Pinzur, Michael
The FDA completed an inspection of Pinzur, Michael on Apr 27, 2009 in Maywood, IL. 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
- Apr 27, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Maywood, IL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |