FDA 483 - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company - February 13, 2026

Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company in Manati, PR, a sterile drug manufacturer, was cited for significant quality control and manufacturing deficiencies during an FDA inspection. Observations included failures in CAPA effectiveness for particulate contamination, inadequate investigation of product quality complaints, insufficient retain samples for testing, and lapses in procedures to prevent microbiological contamination of sterile drug products. These issues indicate a systemic breakdown in quality assurance that could impact drug product quality and patient safety.