FDA 483 - American Regent, Inc. - July 19, 2024

An FDA inspection of AMERICAN REGENT, INC. in Brea, CA, revealed significant deficiencies in the control of computer systems and related records. The firm failed to ensure that changes to master production and control records were instituted only by authorized personnel, and used uncontrolled Excel forms for critical calculations. Additionally, audit trails for certain test equipment were not regularly reviewed, indicating a lack of data integrity oversight.