483
Arthrex, Inc.Arthrex, Inc. – FDA 483, Jan 13, 2025
Record Details
Arthrex, Inc. in Naples, FL, a specification developer, was cited with two observations during an FDA inspection. The firm failed to adequately establish and implement procedures for receiving, reviewing, and evaluating complaints, with instances of complaints closed without proper investigation. Additionally, the firm did not adequately implement its medical device reportable event procedures, resulting in numerous late reports.
View Company Profile
ID · 14aa3216-f2de-4704-9684-27c19ae5bbae
Other documents for Arthrex, Inc.
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.