FDA 483 - Dynasthetics LLC - November 03, 2022

An FDA inspection of Dynasthetics LLC, a medical device manufacturer in Salt Lake City, UT, revealed significant deficiencies in their quality system. The firm was cited for inadequate documentation of process validation activities, insufficient statistical techniques for product and process control, and poorly established procedures for in-process product acceptance. Additionally, the inspection found issues with the firm's records for approved suppliers and contractors.