FDA Inspection 565007 — Tuchek, James, Michael, M.D.
The FDA completed an inspection of Tuchek, James, Michael, M.D. on Mar 11, 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 11, 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 |
|---|---|---|
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2983 | 21 CFR 812.140(a)(2)(iii) | Investigator records of disposition of devices inadequate |