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FDA Inspection
•Richmond University Medical Center•October 16, 2014

Richmond University Medical Center – FDA Inspection, Oct 16, 2014

Record Details

This FDA Inspection record concerns Richmond University Medical Center, with an inspection on October 16, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Richmond University Medical Center
Inspection Date
October 16, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · aae9bd99-6027-48b8-80d2-04a76f3cd677

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
899297
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

3
  1. 21 CFR 606.40(a)(1)Provide space for examination
  2. 21 CFR 606.160(a)(1)Person performing, test results, interpretation
  3. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Richmond University Medical Center

4
DateClassificationOfficeProject area
August 12, 2016VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 23, 2013VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 1, 2010VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 20, 2009VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Richmond University Medical Center
  • FDA Inspection 981289 - 2016-08-12
  • FDA Inspection 821402 - 2013-01-23
  • FDA Inspection 695248 - 2010-11-01
  • FDA Inspection 566824 - 2009-03-20

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