FDA 483 - Caerus Corp. dba Orthocor Medical - April 24, 2019

Caerus Corp. dba Orthocor Medical, a medical device manufacturer in Arden Hills, MN, was inspected and cited for inadequate complaint handling procedures. The firm failed to timely initiate complaint records, conduct and document complete investigations, and adequately assess complaints for Medical Device Report (MDR) reportability.