FDA Inspection 1094790 — Children's National Medical Center
The FDA completed an inspection of Children's National Medical Center on May 31, 2019 in Washington, DC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 31, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Washington, DC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 18089 | 21 CFR 630.10(f)(4) | Physical Assessment Determination - Pulse |
| 18096 | 21 CFR 630.10(g)(2)(ii) | Donor's Acknowledgment - Exculpatory language |
| 18134 | 21 CFR 640.21(g) | Informed consent |
| 251 | 21 CFR 640.25(b) | Quality control |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9243 | 21 CFR 630.40(a) | Notification |