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FDA Inspection
•Spartanburg Regional Health Services IRB•October 2, 2014

Spartanburg Regional Health Services IRB – FDA Inspection, Oct 2, 2014

Record Details

This FDA Inspection record concerns Spartanburg Regional Health Services IRB, with an inspection on October 2, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Spartanburg Regional Health Services IRB
Inspection Date
October 2, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · b1ff33cd-bcfa-405e-aab2-a47f1f6c0139

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
899647
FDA center
Biologics
Project area
Bioresearch Monitoring

FDA Citations

5
  1. 21 CFR 56.115(a)(5)List of members
  2. 21 CFR 56.108(c)Members present for review
  3. 21 CFR 56.115(a)(2)Minutes of IRB meetings
  4. 21 CFR 56.107(e)Conflict of interest
  5. 21 CFR 56.110(c)Method to keep members advised

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Spartanburg Regional Health Services IRB

1
DateClassificationOfficeProject area
February 14, 2019NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for Spartanburg Regional Health Services IRB
  • FDA Inspection 1083994 - 2019-02-14

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