FDA EIR - Bristol Myers Squibb - April 22, 2020

A routine FDA surveillance inspection of Bristol-Myers Squibb in Princeton, NJ, was conducted from April 8 to April 22, 2020. The inspection, requested by the Center for Drug Evaluation and Research (CDER), aimed to assess the firm's compliance with applicable regulations and the Sponsor, Contract Research Organizations, and Monitor Compliance Program (CPGM).

While no Form FDA-483 (Inspectional Observations) was issued, the inspection revealed several discussion items and protocol deviations. A significant issue was the audit trail feature in Bristol-Myers Squibb's SAS system not being activated at the start of a clinical study, preventing complete activity tracking prior to 2018. Management acknowledged this and had already initiated a Corrective and Preventive Action (CAPA) following a 2019 EMA inspection, implementing a modern statistical computing environment with full audit capabilities.

Additionally, the inspection noted multiple instances across various investigator sites where Serious Adverse Events (SAEs) were reported late to Bristol-Myers Squibb, violating Good Clinical Practice (GCP) and protocol requirements. In response, Bristol-Myers Squibb conducted extensive retraining of sites, held management discussions with investigators, and for one site, decided against future study participation. Another issue involved an Institutional Review Board (IRB) suspending enrollment at one site due to an unaddressed information request, which Bristol-Myers Squibb promptly rectified. The FDA advised the company to ensure all system features are active for future studies.