483
APEX Biologix, LLCAPEX Biologix, LLC – FDA 483, Sep 1, 2022
Record Details
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.
- Office
- Denver District Office
- Person
View Company Profile
ID · 08c8ce96-5448-489d-b66a-faa6e6fd7f70
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.