FDA Inspection 912064 — Michael J. Koren, MD

Michael J. Koren, MD — FEI 3005333808

The FDA completed an inspection of Michael J. Koren, MD on Feb 2, 2015 in Jacksonville, FL. 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). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 2, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Jacksonville, FL (United States)

Additional Details

Clinical Investigator (CI)

Citations

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