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FDA Inspection
•St. Joseph's Health Care System IRB•February 17, 2011

St. Joseph's Health Care System IRB – FDA Inspection, Feb 17, 2011

Record Details

This FDA Inspection record concerns St. Joseph's Health Care System IRB, with an inspection on February 17, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
St. Joseph's Health Care System IRB
Inspection Date
February 17, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · dfe7939a-735d-4163-9f98-d7cffae4803d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
715000
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

4
  1. 21 CFR 56.115(a)(5)List of members
  2. 21 CFR 56.109(f)Continuing review
  3. 21 CFR 56.108(a)(1)Initial and continuing reviews
  4. 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution

Full citation text and observation details available on the Dashboard.

Other FDA inspections of St. Joseph's Health Care System IRB

1
DateClassificationOfficeProject area
April 13, 2017NAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for St. Joseph's Health Care System IRB
  • FDA Inspection 1008521 - 2017-04-13

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