FDA 483 - Asahi Intecc Usa Inc - June 01, 2023

Asahi Intecc Usa Inc. in Tustin, CA, was inspected from May 30 to June 1, 2023, and received a Form FDA 483 with two observations. The inspection revealed deficiencies in establishing adequate procedures for design validation, specifically regarding sterilization validation for Crosswalk devices, and for receiving, reviewing, and evaluating product complaints. These issues indicate a need for improved quality system controls.