FDA Inspection
Richmond University Medical CenterRichmond University Medical Center – FDA Inspection, Aug 12, 2016
Record Details
This FDA Inspection record concerns Richmond University Medical Center, with an inspection on August 12, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 12, 2016
- Product Type
- Biologics
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ID · 3a150719-92f0-4c36-b671-6fa8a6ddd4de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 981289
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.40Suitable size, construction, etc.
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
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Other FDA inspections of Richmond University Medical Center
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 23, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 1, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 20, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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