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FDA Inspection
•St Vincent Health•August 26, 2013

St Vincent Health – FDA Inspection, Aug 26, 2013

Record Details

This FDA Inspection record concerns St Vincent Health, with an inspection on August 26, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
St Vincent Health
Inspection Date
August 26, 2013
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 44f37acd-989d-4716-bd25-b32bcab42a2f

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
845879
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

4
  1. 21 CFR 56.115(a)(5)List of members
  2. 21 CFR 56.115(a)(2)Minutes of IRB meetings
  3. 21 CFR 56.109(h)Children as subjects
  4. 21 CFR 56.108(a)(1)Initial and continuing reviews

Full citation text and observation details available on the Dashboard.

Other FDA inspections of St Vincent Health

2
DateClassificationOfficeProject area
January 18, 2018NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
October 22, 2009VAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for St Vincent Health
  • FDA Inspection 1040748 - 2018-01-18
  • FDA Inspection 625446 - 2009-10-22

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