Sharon I Gundersen
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Detailed Analysis
Sharon I Gundersen remains stringent and detail-oriented in her inspections. She consistently looks into accurate and timely documentation, and adherence to the established regulatory process. Patient safety stands out as a high priority in her profiles as she regularly checks for adverse event reports.
From the history of FDA auditor Sharon I Gundersen, it can be inferred that she has a keen eye for ensuring thorough reporting and adherence to regulatory documentations. She appears to prioritize patient safety measures and takes non-compliance with the regulatory process very seriously. She is precise and insists on accurate reporting of device-linked incidents. She seems to have a particularly strong focus on accurate and timely Adverse Event Reports.
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