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FDA Inspection
•University of Miami, Human Subjects Research Office, Medical IRB•December 24, 2015

University of Miami, Human Subjects Research Office, Medical IRB – FDA Inspection, Dec 24, 2015

Record Details

This FDA Inspection record concerns University of Miami, Human Subjects Research Office, Medical IRB, with an inspection on December 24, 2015, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
University of Miami, Human Subjects Research Office, Medical IRB
Inspection Date
December 24, 2015
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 41b95c22-b154-4986-86cd-904fabe5df6c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
955833
FDA center
Foods & Cosmetics
Project area
Bioresearch Monitoring

FDA Citations

2
  1. 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
  2. 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of University of Miami, Human Subjects Research Office, Medical IRB

2
DateClassificationOfficeProject area
April 21, 2016NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
January 12, 2011NAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for University of Miami, Human Subjects Research Office, Medical IRB
  • FDA Inspection 974530 - 2016-04-21
  • FDA Inspection 706147 - 2011-01-12

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