Jeffrey Ralph, M.D.February 9, 2018

FDA 483 - Jeffrey Ralph, M.D. - February 09, 2018

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Record Details

Jeffrey Ralph, M.D., a Sponsor Investigator in San Francisco, CA, was cited for deficiencies during an FDA inspection. The firm failed to conduct an investigation in accordance with the investigational plan, lacking sufficient documentation for required subject procedures. Additionally, the firm did not ensure timely Institutional Review Board (IRB) approval for a clinical study, allowing approval periods to expire on multiple occasions.

Company: Jeffrey Ralph, M.D.
Inspection Date: February 9, 2018
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West V
People: Susan K. Cummins
Dustin Tran (Investigator )

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ID · ab0c38f8-ceaa-44b7-bf7f-99d6731630ba