FDA 483 - BBS Enterprises, DBA Complexus Medical - April 12, 2023

BBS Enterprises, DBA Complexus Medical, a medical device manufacturer in Mishawaka, IN, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for receiving and investigating customer complaints, as evidenced by incomplete feedback forms. Additionally, process control procedures were found to be inadequate, with manufacturing operations using process parameter settings that were outside validated ranges without objective evidence of validation.