FDA 483 - American Regent, Inc. - January 29, 2026

American Regent, Inc. in New Albany, OH, a sterile drug manufacturer, received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into batch failures, sterility issues, and out-of-specification results. Additionally, the firm failed to adequately manage supplier quality and adhere to aseptic manufacturing procedures, indicating a systemic breakdown in their quality management system.