FDA Inspection 764442 — University Of Texas Southwestern Medical Center, The

University Of Texas Southwestern Medical Center, The — FEI 3012367823

The FDA completed an inspection of University Of Texas Southwestern Medical Center, The on Jan 23, 2012 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 23, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Dallas, TX (United States)

Additional Details

IRB

Citations

IDCFRDescription
728121 CFR 56.108(a)(1)Initial and continuing reviews
735321 CFR 50.52Factors required for approval

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