FDA Inspection 1021230 — Ashutosh P. Jadhav, MD, PhD

Ashutosh P. Jadhav, MD, PhD — FEI 3013399856

The FDA completed an inspection of Ashutosh P. Jadhav, MD, PhD on Aug 11, 2017 in Pittsburgh, PA. 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). 3 citations were issued during this inspection. Product area: Devices.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Aug 11, 2017
Fiscal Year
2017
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
722721 CFR 50.27(a)Consent form not approved/signed/dated

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