FDA 483 - Bristol-Myers Squibb Company - December 06, 2024

Bristol-Myers Squibb Company, located in Madison, NJ, received a Form 483 for deficiencies in its Risk Evaluation and Mitigation Strategy (REMS) for THALOMID. The inspection revealed failures in adhering to the REMS audit schedule, monitoring patient pregnancy tests, and providing complete training materials to healthcare providers and pharmacies. These issues indicate a lack of robust controls in ensuring the safe use and distribution of the drug.