FDA 483 - American Regent, Inc. - December 09, 2022

American Regent, Inc., a sterile drug manufacturer in New Albany, OH, was inspected by the FDA. The inspection revealed significant issues including inadequate procedures to prevent microbiological contamination, deficiencies in employee training for visual inspection, and incomplete investigations into manufacturing discrepancies. These observations highlight concerns regarding the firm's quality control and adherence to sterile manufacturing practices.