Biologics

Most Common 2022 BIMO Violations

Three Goodwin attorneys analyzed Warning Letters issued following Bioresearch Monitoring (BIMO) program inspections in 2022. Their online post says that BIMO conducted 504 inspections of clinical investigators in FY 2022. Of the 504, nine resulted in a classification of “official action indicated” and 87 resulted in a classification of “voluntary action indicated.”

The most common inspection observations, the attorneys write, were failing to comply with form FDA-1372 requirements and protocol compliance, failing to follow the investigational plan and protocol deviations, inadequate and/or inaccurate case history records and inadequate study records, inadequate accountability and/or control of the investigational product, safety reporting and failing to report and/or record adverse events, and inadequate subject protection and informed consent issues.

In the Warning Letters that were issued in FY 2022 to clinical investigators, the post says, the most common observations were:

failing to ensure that a clinical investigation was conducted according to its investigational plan; and
failing to submit an IND application for the conduct of a clinical investigation with an investigational new drug.

In the 81 inspections of sponsors and contract research organizations in FY2022, the attorneys say the most common inspection observations were:

failing to ensure proper monitoring of the study and ensure that the study is conducted in accordance with the protocol and/or investigational plan;
failing to meet the abbreviated requirements for investigational device exemptions;
failing to maintain and/or retain adequate records in accordance with regulations;
accountability for the investigational product;
failing to comply with form FDA-1572 requirements;
financial disclosures;
failing to submit an IND and IND safety reports; and
failing to submit the current list of all participating investigators to FDA at the six-month interval after agency approval of a study.

The attorneys report that so far in 2023, there have been six form FDA-483 Warning Letters issued to clinical investigators and institutional review boards (IRBs). Three involved failing to submit an IND for the conduct of a clinical investigation with an investigational new drug; two involved failing to follow the clinical investigation according to the investigational plan, and one involved an overall lack of IRB oversight and IRB compliance.

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