FDA 483 - Bristol-Myers Squibb Company - July 08, 2025

Bristol-Myers Squibb Company in Devens, MA, was cited for four observations related to its biologic drug substance manufacturing. The inspection revealed significant issues including recurrent mold contamination in manufacturing and storage areas, inadequate qualification of critical equipment, deficiencies in raw material specifications and sampling plans, and a failure to properly investigate manufacturing deviations and component failures. These issues indicate a lack of robust quality control and environmental management.