FDA Inspection 1035273 — Michael J. Pelekanos, MD
The FDA completed an inspection of Michael J. Pelekanos, MD on Nov 28, 2017 in Oakmont, PA. 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
- Nov 28, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Oakmont, PA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2973 | 21 CFR 812.110(a) | Subject participation prior to study approval |
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |