FDA Inspection 854685 — Lisa M. Cibik, M.D.
The FDA completed an inspection of Lisa M. Cibik, M.D. on November 14, 2013 in West Mifflin, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 14, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- West Mifflin, 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 |