FDA Inspection 572686 — Thomas Zellers
The FDA completed an inspection of Thomas Zellers on Mar 20, 2009 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 20, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Dallas, TX (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 |
| 3021 | 21 CFR 812.150(a)(1) | Investigator report of unanticipated adverse effects |
| 3065 | 21 CFR 812.140(a)(5) | Additional investigator records FDA requires |