FDA Inspection
Richmond University Medical CenterRichmond University Medical Center – FDA Inspection, Jan 23, 2013
Record Details
This FDA Inspection record concerns Richmond University Medical Center, with an inspection on January 23, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 23, 2013
- Product Type
- Biologics
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ID · afd0f2cb-e061-4488-9298-af8b78acafc4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 821402
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.171Biological product deviation report
- 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 |
| 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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