FDA Inspection 823497 — Dennis J. Hurwitz, M.D.
The FDA completed an inspection of Dennis J. Hurwitz, M.D. on April 2, 2013 in Pittsburgh, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 2, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Pittsburgh, PA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |
| 3025 | 21 CFR 812.150(a)(3) | No investigator progress reports |
| 3027 | 21 CFR 812.150(a)(4) | Investigator non-emergency safety or soundness changes |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |