FDA 483 - Concha Inc. - March 27, 2026

Concha Inc. in San Mateo, CA, a manufacturer of Concha Sol Hearing Aids, received a Form FDA 483 citing significant deficiencies across its quality management system. The inspection revealed systemic failures in design control, supplier qualification, complaint handling, and critical QMS oversight functions like internal audits and management reviews. These issues indicate a lack of robust processes to ensure device safety and performance throughout development and commercial distribution.