FDA Inspection
Reston Hospital CenterReston Hospital Center – FDA Inspection, Dec 9, 2016
Record Details
This FDA Inspection record concerns Reston Hospital Center, with an inspection on December 9, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 2f3aa234-f2c9-4400-b925-4d33a849f1fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996122
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 600.12(b)(1)Retention - General
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Other FDA inspections of Reston Hospital Center
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| December 15, 2010 | VAI | 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 914901 - 2015-02-20
- FDA Inspection 842820 - 2013-08-02
- FDA Inspection 702224 - 2010-12-15
- FDA Inspection 615396 - 2009-09-30
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