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

AMERICAN REGENT, INC. was issued an FDA Form 483 following an inspection conducted from July 15 to July 19, 2024, at its Brea, CA manufacturing facility. The inspection revealed critical issues regarding data integrity and control over computer systems and records, particularly impacting the manufacturing of Paclitaxel Albumin-Bound Bulk Suspension. Key observations included a lack of appropriate controls to ensure only authorized personnel make changes to master production and control records. Specifically, analysts and quality control reviewers possessed abilities to add or modify audit trail entries on HPLC and GC systems, and quality control reviewers had extensive permissions on UV/Vis systems, such as editing queries and managing methods. Additionally, the firm was found using uncontrolled and unapproved Excel spreadsheets for critical test result calculations for assay, albumin content, particle size, and residual solvent. Furthermore, audit trails for certain test equipment were not routinely reviewed. These findings indicate a need for AMERICAN REGENT, INC. to implement robust corrective and preventive actions to enhance data integrity, restrict unauthorized system access, validate all calculation tools, and establish routine audit trail reviews to comply with good manufacturing practices. The company is expected to provide a comprehensive response detailing its remediation plan.