FDA Inspection 766112 — U. Of Connecticut Hlth Ctr. IRB

U. Of Connecticut Hlth Ctr. IRB — FEI 1283252

The FDA completed an inspection of U. Of Connecticut Hlth Ctr. IRB on Feb 3, 2012 in Farmington, CT. 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). 4 citations were issued during this inspection. Product area: Drugs.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 3, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Farmington, CT (United States)

Additional details

IRB

Citations

IDCFRDescription
728121 CFR 56.108(a)(1)Initial and continuing reviews
730521 CFR 56.110(b)(2)Minor changes
732121 CFR 56.110(c)Method to keep members advised
739321 CFR 50.25(a)(8)Participation; refusal and discontinuance

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.