FDA Inspection
MedStar Georgetown Medical Center Inc Georgetown University HospitalMedStar Georgetown Medical Center Inc Georgetown University Hospital – FDA Inspection, Sep 10, 2019
Record Details
This FDA Inspection record concerns MedStar Georgetown Medical Center Inc Georgetown University Hospital, with an inspection on September 10, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 10, 2019
- Product Type
- Biologics
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ID · dfc0dc05-e5ac-4459-8f0a-8d8ec47fdddc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1107397
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 606.100(b)SOPs for investigations, records
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Other FDA inspections of MedStar Georgetown Medical Center Inc Georgetown University Hospital
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 24, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 27, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 9, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 26, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for MedStar Georgetown Medical Center Inc Georgetown University Hospital
- FDA Inspection 1234681 - 2024-03-18
- FDA Inspection 1008520 - 2017-03-24
- FDA Inspection 923807 - 2015-04-27
- FDA Inspection 826516 - 2013-04-09
- FDA Inspection 777775 - 2012-04-26
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