BIMO Inspections – GCP Dilema

BIMO stands for Bioresearch Monitoring. The FDA releases each year, a list of findings for FDA-regulated product that may be in violation of the agency’s requirements. These inspections’ findings are listed on an FDA Form 483 by the inspector. Last year, there were over 600 findings from different FDA’s BIMO program (i.e., clinical investigators, IRBs,Continue reading “BIMO Inspections – GCP Dilema”