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FDA Inspection
•Bridgeport Hospital IRB•December 16, 2010

Bridgeport Hospital IRB – FDA Inspection, Dec 16, 2010

Record Details

This FDA Inspection record concerns Bridgeport Hospital IRB, with an inspection on December 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Bridgeport Hospital IRB
Inspection Date
December 16, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · bb8aa04e-b230-4072-ab58-254b0f6ff0cb

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
705335
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

3
  1. 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
  2. 21 CFR 56.108(c)Members present for review
  3. 21 CFR 56.108(a)(1)Initial and continuing reviews

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Bridgeport Hospital IRB

1
DateClassificationOfficeProject area
April 7, 2016NAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for Bridgeport Hospital IRB
  • FDA Inspection 966739 - 2016-04-07

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