FDA Inspection
Reston Hospital CenterReston Hospital Center – FDA Inspection, Dec 15, 2010
Record Details
This FDA Inspection record concerns Reston Hospital Center, with an inspection on December 15, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Reston Hospital Center
- Inspection Date
- December 15, 2010
- Product Type
- Biologics
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ID · 5610048b-06e8-43fd-9263-963c55142204
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702224
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Reston Hospital Center
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 20, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 2, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 30, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Reston Hospital Center
- FDA Inspection 996122 - 2016-12-09
- FDA Inspection 914901 - 2015-02-20
- FDA Inspection 842820 - 2013-08-02
- FDA Inspection 615396 - 2009-09-30
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