FDA Inspection 1028855 — Ronald F. Budzik Jr., MD

Ronald F. Budzik Jr., MD — FEI 3013662418

The FDA completed an inspection of Ronald F. Budzik Jr., MD on October 17, 2017 in Columbus, OH. 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
October 17, 2017
Fiscal Year
2018
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Columbus, OH (United States)

Additional Details

Clinical Investigator (CI)

Citations

IDCFRDescription
296821 CFR 812.100Investigator non-compliance with agreement/plan/regulations
298421 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate