FDA 483 - IntriCon Corp - April 17, 2023

An FDA inspection of IntriCon Corp, a contract manufacturer in Vadnais Heights, MN, revealed inadequate procedures for preventing contamination and handling contaminated product. The firm experienced multiple contamination incidents involving medical device components, failing to properly document review, approval, and disposition of affected products or work areas. This indicates a significant lapse in quality control and contamination prevention protocols.