FDA 483 - Novartis d.o.o. - February 09, 2024

The FDA issued a Form 483 to Novartis d.o.o. following an inspection conducted at its manufacturing facility in Ljubljana, Slovenia, from January 29 to February 9, 2024. The inspection highlighted several issues regarding the firm's adherence to manufacturing quality standards. A primary observation noted the lack of routine calibration and checking for automatic equipment, specifically a check weigher used for capsule manufacturing, which was not periodically assessed for repeatability and accuracy. Another concern involved the inadequate annual review of reserve drug product samples; the visual examination only covered the external container appearance, failing to evaluate the drug product itself for deterioration. Additionally, equipment cleaning and sanitization protocols were found to be insufficiently validated, as a Dirty Hold Time study did not incorporate worst-case manufacturing conditions. Novartis d.o.o. is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure full compliance with regulatory expectations for drug manufacturing quality and safety.