FDA Inspection
Richmond University Medical CenterRichmond University Medical Center – FDA Inspection, Nov 1, 2010
Record Details
This FDA Inspection record concerns Richmond University Medical Center, with an inspection on November 1, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 1, 2010
- Product Type
- Biologics
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ID · 7d0fe33d-f81a-4426-b3dd-059eb7a57804
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 695248
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| March 20, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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