FDA Provides Best Practices for Responding to BIMO Inspection 483s
June 7, 2024 at 09:58 AM EST
The FDA’s new draft guidance on processes and practices applicable to Bioresearch Monitoring (BIMO) inspections provides clinical investigators with best practices for responding in writing to a Form FDA 483 resulting from an inspection. A response should:
demonstrate the establishment’s acknowledgment and understanding of FDA’s observations;
demonstrate the establishment’... Read More
