Jonathan E. Isaacs, M.D.February 28, 2025

FDA 483 - Jonathan E. Isaacs, M.D. - February 28, 2025

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Record Details

Jonathan E. Isaacs, M.D., a clinical investigator in Richmond, VA, was cited with two observations during an FDA inspection. The firm failed to provide complete temperature logs for an investigational product throughout a clinical trial, hindering record verification. Additionally, a serious adverse event was not reported promptly to the sponsor, exceeding the protocol-specified timeframe.

Company: Jonathan E. Isaacs, M.D.
Inspection Date: February 28, 2025
Product Type: Other
Office: Office of Regulatory Affairs
Person: Lucilla Facchin

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ID · 22ffc98d-d6ff-40f0-8d9c-23c1dd2b1d51