FDA Inspection 1024156 — Jeffrey Kline

Jeffrey Kline — FEI 3013659985

The FDA completed an inspection of Jeffrey Kline on September 6, 2017 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 6, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Indianapolis, IN (United States)

Additional Details

Clinical Investigator (CI)

Citations

IDCFRDescription
753021 CFR 312.62(b)Case history records- inadequate or inadequate
755221 CFR 312.66Changes in research
756021 CFR 312.60FD-1572, protocol compliance