FDA Inspection 845896 — Dr. Constance M. Westhoff @ NYBC
The FDA completed an inspection of Dr. Constance M. Westhoff @ NYBC on September 12, 2013 in Long Island City, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 12, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Long Island City, NY (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2994 | 21 CFR 812.140(b)(3) | Sponsor records of investigator agreements inadequate |
| 3064 | 21 CFR 812.140(a)(4) | Investigator protocol records inadequate |
| 3065 | 21 CFR 812.140(a)(5) | Additional investigator records FDA requires |