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
- Bioresearch Monitoring (BIMO) Metrics – FY21
The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.Sign up to receive Recalls, Market Withdrawals and Safety Alerts.
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