FDA 483 - Novartis Gene Therapies, Inc. - August 02, 2019

AveXis, Inc. in San Diego, CA, a control testing lab, was cited for significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate unexplained discrepancies, maintain complete laboratory records, and ensure proper quality control unit responsibilities. Additionally, issues were noted with the testing and standardization of reference standards and adherence to established test procedures, indicating systemic quality control and data integrity concerns.