FDA 483 - Novartis Gene Therapies, Inc.

AveXis, Inc. in Libertyville, IL, was cited with 13 observations during an FDA inspection from February 4-8, 2019. The inspection revealed significant deficiencies in quality control, including failures to follow written procedures, inadequate corrective actions for recurring issues, and a lack of essential written procedures for critical manufacturing and labeling processes. Multiple instances of product control issues, such as incorrect labeling and conditional release without proper testing, were noted, alongside recurring mold contamination in cleanroom environments.