FDA Inspection 766399 — Keith Atassi, M.D.
The FDA completed an inspection of Keith Atassi, M.D. on Feb 3, 2012 in Valparaiso, IN. 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
- Feb 3, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Valparaiso, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14508 | 21 CFR 812.140(a)(4) | Investigator record of protocol deviations inadequate |
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |