FDA 483 - Astron Dental Corp - March 18, 2022

Astron Dental Corp, a medical device manufacturer in Lake Zurich, IL, was inspected by the FDA and received two observations. The inspection revealed issues with the validation of software used in the production of Original CLEARsplint Discs and a lack of established procedures for acceptance activities for these same devices. These findings indicate significant deficiencies in the firm's quality system regarding manufacturing process control and product acceptance.