FDA 483 - Signifier Medical Technologies, Llc - July 15, 2022

Signifier Medical Technologies, Llc, a medical device manufacturer, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures. The inspection revealed incomplete corrective action reports, missed due dates, and a failure to adequately address U.S. regulatory requirements under 21 CFR 820.100. These issues indicate a lack of robust quality system controls.