James ForanJune 20, 2025

FDA 483 - James Foran - June 20, 2025

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Record Details

The FDA inspected Mayo Clinic in Jacksonville, FL, a clinical investigator site, and issued a Form 483 with two observations. The inspection revealed deficiencies in adhering to the investigational plan, including missed laboratory assessments and sample collections. Additionally, the firm failed to maintain adequate and accurate case histories, with issues related to unattributed corrections and documentation.

Company: James Foran
Inspection Date: June 20, 2025
Product Type: Drugs
Office: Florida District Office
Person: Emily C. Caldwell (investigator)

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ID · 5f925758-c658-4100-81d9-48bcb75a6efb