FDA Inspection 773129 — Anita P. Courcoulas, MD

Anita P. Courcoulas, MD — FEI 3009153697

The FDA completed an inspection of Anita P. Courcoulas, MD on March 21, 2012 in Pittsburgh, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 21, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Pittsburgh, PA (United States)

Additional Details

Clinical Investigator (CI)

Citations

IDCFRDescription
1450521 CFR 812.140(a)(3)Investigator's subject records inadequate
297421 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations