FDA Inspection 607287 — National institutes of Health (NIH) Clinical Center
The FDA completed an inspection of National institutes of Health (NIH) Clinical Center on August 21, 2009 in Bethesda, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 21, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bethesda, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |