FDA Inspection 808742 — Providence Hospital Institutional Review Board

Providence Hospital Institutional Review Board — FEI 1120141

The FDA completed an inspection of Providence Hospital Institutional Review Board on November 20, 2012 in Washington, DC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 20, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Washington, DC (United States)

Additional Details

IRB

Citations

IDCFRDescription
733521 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)