FDA EIR - Bristol Myers Squibb - February 02, 2022

A routine surveillance inspection of Bristol Myers Squibb (Princeton, NJ) was conducted by the FDA from January 21 to February 2, 2022. The inspection, carried out under the Sponsor, Contract Research Organizations and Monitor Compliance Program (CPGM) 7348.810, aimed to ensure compliance with regulations governing Investigational New Drug (IND) and New Drug Application (NDA) studies. No official Form FDA-483 Inspectional Observations were issued. However, a significant discussion item with management centered on inadequate training for Sub-Investigators who performed efficacy assessments prior to completing mandatory training modules. Management acknowledged the issue, clarifying the distinction between protocol and Clinical Management Plan requirements. The inspection also reviewed Bristol Myers Squibb’s internal corrective actions for several critical issues. These included a system failure that led to 106 subjects being incorrectly assigned treatment, prompting updates to Standard Operating Procedures (SOPs) and enhanced User Acceptance Testing (UAT) processes. Furthermore, a clinical site (site 092) was terminated due to egregious non-compliance, such as late data entry, incorrect subject numbering, and assessments performed by unqualified personnel, resulting in the exclusion of its study data. Bristol Myers Squibb implemented internal corrective and preventative actions, including revising partnership guidance with vendors to strengthen oversight of UAT plans and reports. The FDA noted that modules for copyrighted training should be made available for future review.