FDA 483 - Xintec Corp - June 07, 2022

Xintec Corp, a manufacturer of the Odyssey 30 Rev.B1 Laser System in Alameda, CA, was cited for multiple significant quality system deficiencies during an FDA inspection. Observations included inadequate process controls, lack of acceptance activity procedures, incomplete device history records, poor document control, and failure to investigate customer complaints. This indicates a systemic breakdown in their quality management system, with one observation being a repeat violation.