Novartis Gene Therapies, Inc. – FDA 483, Jun 16, 2021

Novartis Gene Therapies, Inc. in Libertyville, IL, received a Form 483 with five observations during an FDA inspection of its gene therapy manufacturing facility. The inspection revealed significant deficiencies in laboratory controls, including inadequate procedures for OOS/OOT investigations, trending invalid analytical tests, and identifying Out of Expectation results. Additionally, the firm failed to retain reserve samples for drug products, lacked appropriate specifications for component quality, and had incomplete laboratory records.