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

Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company in Manati, PR, received a Form 483 citing significant quality control deficiencies during an inspection from January to February 2026. Observations included ineffective corrective actions for foreign particulates in sterile drug products, inadequate investigation of product quality complaints, and insufficient reserve samples for testing. Additionally, the firm failed to follow procedures to prevent microbiological contamination, indicating a moderate level of non-compliance.