FDA 483 - APEX Biologix, LLC - September 01, 2022

An FDA inspection of APEX Biologix, LLC, a biological medical device manufacturer in Woods Cross, UT, revealed significant deficiencies in the firm's quality system. The inspection cited inadequate document control procedures, specifically concerning the review and approval of documents. Additionally, the firm's complaint handling procedures were found to be insufficiently established, leading to concerns about uniform and timely complaint processing.