FDA EIR - Bristol-Myers Squibb Company - June 03, 2020

An FDA inspection of Bristol Myers Squibb (formerly Celgene) at its Summit, NJ facility was conducted from May 26 to June 3, 2020. This pre-announced, high-priority inspection, guided by Compliance Program Guidance Manual 7348.810 for Sponsors, Contract Research Organizations, and Monitors, evaluated various aspects of the firm's clinical trial operations, including monitoring adequacy, protocol deviations, adverse event reporting, and record retention.

Significantly, no Form FDA-483, Inspectional Observations, was issued at the conclusion of the inspection. However, two discussion items were raised with management. Firstly, the FDA noted the absence of a formalized User Acceptance Testing (UAT) procedure prior to performing UAT activities, suggesting a need for better documentation. Secondly, a delay was identified in resolving a protocol deviation at Site 401, where a lack of Principal Investigator oversight was first noted in March 2016 and not resolved until May 2017. While the issue was eventually corrected, the FDA suggested the sponsor could have provided more timely oversight.

Bristol Myers Squibb management acknowledged these discussion items, expressing appreciation for the feedback and committing to address them by modifying their procedures to enhance future FDA audits. No samples were collected, and no refusals were encountered during the inspection.