FDA Inspection
Richmond University Medical CenterRichmond University Medical Center – FDA Inspection, Mar 20, 2009
Record Details
This FDA Inspection record concerns Richmond University Medical Center, with an inspection on March 20, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 20, 2009
- Product Type
- Biologics
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ID · 84a1cb56-405c-47cc-ba51-91208ac4615b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 566824
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 211.194(a)(7)Signatures and dates--person who performs test
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Richmond University Medical Center
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| 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 |
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