FDA Inspection 607269 — Children's National Medical Center
The FDA completed an inspection of Children's National Medical Center on August 13, 2009 in Washington, DC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 13, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Washington, DC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 75 | 21 CFR 606.100(a) | SOP compliance |
| 9225 | 21 CFR 606.171 | Biological product deviation report |