483
James ForanFDA 483 - James Foran - June 20, 2025
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.
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ID · 5f925758-c658-4100-81d9-48bcb75a6efb