FDA EIR - Bristol-Myers Squibb Company - March 14, 2022

A routine surveillance Sponsor Inspection of Bristol Myers Squibb (BMS) in Summit, NJ, was conducted by the FDA from March 7 to March 14, 2022. This inspection, requested by the Center for Drug Evaluation and Research (CDER), aimed to assess BMS's compliance with applicable regulations and the Sponsor, Contract Research Organizations and Monitor Compliance Program (CPGM) 7348.810. The review encompassed two clinical studies, including study (b) (4), along with contract agreements, vendor and investigator qualifications, study plans, monitoring reports, and quality assurance activities. A significant point of discussion at the closeout meeting concerned the inconsistent completion of Serious Adverse Event (SAE) forms by clinical sites. Specifically, follow-up SAE forms were sometimes submitted lacking essential details such as the Common Terminology Criteria for Adverse Events (CTCAE) grade or seriousness criteria. This inconsistency potentially impacts the comprehensive evaluation of patient safety events, as the clinical site provides the primary information. Despite this observation, the inspection concluded with a "No Action Indicated (NAI)" classification, indicating no formal inspectional observations (FDA Form 483) were issued. BMS acknowledged the finding, but did not present a detailed plan for corrective actions during the closeout discussion. No samples were collected, and no refusals were encountered.