FDA Inspection
MedStar Franklin Square Medical CenterMedStar Franklin Square Medical Center – FDA Inspection, Jun 22, 2009
Record Details
This FDA Inspection record concerns MedStar Franklin Square Medical Center, with an inspection on June 22, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 22, 2009
- Product Type
- Biologics
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ID · 092feed2-d659-4707-924b-3f04c7d59be5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 593220
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.171Biological product deviation report
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of MedStar Franklin Square Medical Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 29, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 23, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 2, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 31, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 26, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for MedStar Franklin Square Medical Center
- FDA Inspection 1108990 - 2019-10-29
- FDA Inspection 1063782 - 2018-08-23
- FDA Inspection 950876 - 2015-11-02
- FDA Inspection 865188 - 2014-01-31
- FDA Inspection 779195 - 2012-04-26
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