FDA 483 - Syntech International, Inc - September 19, 2025

Syntech International, Inc. in Irvine, CA, a manufacturer of MAXAIR devices, was cited for two significant issues during an FDA inspection. The firm failed to adequately maintain complaint files for numerous cable failures and did not register any of its MAXAIR devices on the Global Unique Device Identification Database (GUDID). These observations indicate deficiencies in quality system processes related to complaint handling and device identification.