FDA 483 - Inmedix, Inc. - March 20, 2026

Inmedix, Inc. in Normandy Park, WA, was cited for three significant issues during an FDA inspection. The firm failed to adequately validate software for its Class II CloudHRV System, did not process nine out of eleven complaints in a timely manner, and lacked documented procedures and evidence for management reviews of its quality management system. These observations indicate deficiencies in design control, complaint handling, and overall quality system management.