Norman LeporMay 28, 2014

FDA 483 - Norman Lepor - May 28, 2014

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Record Details

An FDA inspection of Dr. Norman E. Lepor, a Principal Investigator at Westside Medical Associates of LA, identified an issue with investigational drug disposition records. Specifically, the records for a study lacked complete information regarding the dates and quantities of drugs returned by subjects. This indicates a deficiency in maintaining adequate documentation for clinical trials.

Company: Norman Lepor
Inspection Date: May 28, 2014
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
Person: Comyar Shoghi (investigator)

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ID · c966a475-dce7-4c24-b47e-78ad1d91fc98