FDA 483 - SAFC Carlsbad Inc. - August 14, 2025

An FDA inspection of SAFC Carlsbad Inc., a viral vector manufacturer, revealed a significant failure to adhere to and establish written procedures for manufacturing equipment. Specifically, the firm did not perform required maintenance and testing on equipment according to its own SOPs for several years, and lacked procedures for tracking and maintaining other critical equipment. This indicates a lapse in quality control and adherence to established manufacturing practices.