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FDA Inspection
•OSF St. Anthony Medical Center IRB•July 20, 2017

OSF St. Anthony Medical Center IRB – FDA Inspection, Jul 20, 2017

Record Details

This FDA Inspection record concerns OSF St. Anthony Medical Center IRB, with an inspection on July 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
OSF St. Anthony Medical Center IRB
Inspection Date
July 20, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Denise L. Burosh (FDA Associated Person)
View Company Profile

ID · adf79c64-4726-447a-8344-377d39d63652

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1018669
FDA center
Human Drugs
Project area
Bioresearch Monitoring
Outcome
Form 483 issued

FDA Citations

3
  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

Full citation text and observation details available on the Dashboard.

Other FDA inspections of OSF St. Anthony Medical Center IRB

1
DateClassificationOfficeProject area
July 15, 2011NAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for OSF St. Anthony Medical Center IRB
  • FDA Inspection 741969 - 2011-07-15

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