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FDA Inspection
•Ascension Sacred Heart Hospital IRB•May 11, 2010

Ascension Sacred Heart Hospital IRB – FDA Inspection, May 11, 2010

Record Details

This FDA Inspection record concerns Ascension Sacred Heart Hospital IRB, with an inspection on May 11, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Ascension Sacred Heart Hospital IRB
Inspection Date
May 11, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · fe7fbf4c-7a91-4d27-a8e4-37099a62edc5

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
661920
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

1
  1. 21 CFR 56.104(c)Emergency use and IRB approval

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ascension Sacred Heart Hospital IRB

2
DateClassificationOfficeProject area
August 10, 2022VAICenter for Devices and Radiological HealthBioresearch Monitoring
June 23, 2015VAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for Ascension Sacred Heart Hospital IRB
  • FDA Inspection 1177253 - 2022-08-10
  • FDA Inspection 932404 - 2015-06-23

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