FDA Draft Guidance for Bioresearch Monitoring Program Contains General Best Practices for FDA Inspections

Lexology June 11, 2024
Greenberg Traurig LLP

Go-To Guide:

• Prior to an inspection, FDA may inform establishment staff of which documents must be made available for viewing and/or copying while FDA is on site.
• If establishment staff orally respond to FDA’s observations during the inspection, FDA may include those responses in its inspection report.
• Providing a thorough and timely written response to a Form FDA 483 can help minimize subsequent enforcement risks.

On June 4, 2024, the U.S. Food and Drug Administration released draft guidance titled Processes and Practices Applicable to Bioresearch Monitoring Inspections (Draft Guidance) that describes FDA’s approach to conducting inspections of sites and facilities engaging in bioresearch activities subject to FDA regulation under its Bioresearch Monitoring (BIMO) program. While some of FDA’s...

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