BIMO Inspection Metrics

The slides accessed through the links below provide annual bioresearch monitoring (BIMO) inspection metrics by fiscal year (FY). The inspectional data cover all aspects of FDA’s BIMO program (i.e., clinical investigators, IRBs, sponsors, bioequivalence, and good laboratory practices) for all Centers, as applicable. These data were provided by the individual Centers and may differ from other inspection data available on FDA’s website, as different criteria and/or methods for compiling the information may have been used. Also provided, at the first link below, is a glossary of acronyms.

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This page lists the most recent reports. Metrics from previous years can be found in the FDA.gov Archive.

Annual BIMO Inspection Metrics

• Acronyms Used in Metric Slides

FY2023

• Bioresearch Monitoring (BIMO) Metrics – FY23
  • FY 2023 IRB FDA 483 Observation Trends
  • FY 2023 GLP FDA 483 Observation Trends
  • FY 2023 Clinical Investigator FDA 483 Observation Trends
  • FY 2023 Sponsor FDA 483 Observation Trends

FY2022

• Bioresearch Monitoring (BIMO) Metrics – FY22
  • FY 2022 IRB FDA 483 Observation Trends
  • FY 2022 GLP FDA 483 Observation Trends
  • FY 2022 Clinical Investigator FDA 483 Observation Trends
  • FY 2022 Sponsor FDA 483 Observation Trends

FY2021

• Bioresearch Monitoring (BIMO) Metrics – FY21
  • FY 2021 Clinical Investigator FDA 483 Observation Trends
  • FY 2021 Sponsor FDA 483 Observation Trends
  • FY 2021 GLP FDA 483 Observation Trends

FY2020

• Bioresearch Monitoring (BIMO) Metrics – FY’20
  • FY 2020 GLP FDA 483 Observation Trends
  • FY 2020 Clinical Investigator FDA 483 Observation Trends

Years Prior to 2020

• Bioresearch Monitoring (BIMO) Metrics - FY'19
• Bioresearch Monitoring (BIMO) Metrics - FY'18
• Bioresearch Monitoring (BIMO) Metrics - FY'17
• Bioresearch Monitoring (BIMO) Metrics - FY'16
• Bioresearch Monitoring (BIMO) Metrics - FY'15