FDA EIR - Bristol-Myers Squibb Company - February 19, 2021

An FDA pre-licensing inspection of Celgene, a Bristol-Myers Squibb Company, located in Summit, NJ, was conducted from February 15-19, 2021. This initial inspection focused on the manufacturing of the biological drug product idecabtagene vicleucel (ide-cel), a CAR T Cell therapy, under the guidance of CPGM 7345.848 for Biological Drug Products. The inspection covered all six quality systems, including Quality, Production, Facilities and Equipment, Materials, Laboratory, and Packaging and Labeling. At the conclusion, an FDA-483 was issued to the Vice President/Site Lead, Mr. Charles Bruce Phillips Jr., detailing three main observations. These included the absence of established procedures to prevent objectionable microorganisms in drug products, non-adherence to quality control unit responsibilities and procedures, and a lack of written processes to connect escalated deviations with potential product recalls or Biological Product Deviation Reporting for issues discovered post-release. Additionally, discussions during the close-out meeting highlighted concerns regarding SOP discrepancies, inadequate response to critical alarms, insufficient deviation reporting for all affected lots, and substandard cold room storage conditions. The company's practice of releasing drug products with open deviations and issues with deviation classification and documentation of chain of identity checks were also noted. Mr. Phillips acknowledged the observations and committed to providing a written response within 15 days, indicating the need for corrective actions to address these deficiencies before commercial launch.