FDA 483 - Acutus Medical Inc - December 09, 2022

An FDA inspection of Acutus Medical Inc in Carlsbad, CA, from December 5-9, 2022, revealed four significant quality system deficiencies. The firm failed to adequately validate a critical manufacturing process, establish proper procedures for monitoring and controlling validated processes, and ensure adequate complaint handling procedures. Additionally, procedures to prevent contamination in the clean room were found to be insufficient.