FDA 483 - Novartis Gene Therapies, Inc. - August 23, 2021

Novartis Gene Therapies in San Diego, CA, a control testing laboratory, was inspected by the FDA. The inspection revealed significant deficiencies in the control of laboratory reagents, including a lack of written procedures for qualifying non-critical reagents, inadequate vendor qualification, and failure to follow established SOPs for assigning expiry dates and ensuring traceability of reagents. These issues were observed during the release and stability testing of the Zolgensma drug product and drug substance.