FDA Inspection
Children's National Medical CenterChildren's National Medical Center – FDA Inspection, May 31, 2019
Record Details
This FDA Inspection record concerns Children's National Medical Center, with an inspection on May 31, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · cb9d7fe1-91ed-460f-860c-908bd6ba2a33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094790
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 640.21(g)Informed consent
- 21 CFR 630.10(f)(4)Physical Assessment Determination - Pulse
- 21 CFR 630.40(a)Notification
- 21 CFR 606.171Biological product deviation report
- 21 CFR 640.25(b)Quality control
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
- 21 CFR 630.10(g)(2)(ii)Donor"s Acknowledgment - Exculpatory language
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 630.10(g)(2)(ii)Donor's Acknowledgment - Exculpatory language
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Other FDA inspections of Children's National Medical Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 19, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| October 5, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 13, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 29, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Children's National Medical Center
- FDA Inspection 1251219 - 2024-09-27
- FDA Inspection 1178672 - 2022-08-19
- FDA Inspection 989211 - 2016-10-05
- FDA Inspection 871610 - 2014-03-13
- FDA Inspection 788917 - 2012-06-29
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