FDA 483 - Titan Spine, LLC - December 11, 2017

Titan Spine, LLC, a medical device manufacturer in Milwaukee, WI, received an FDA Form 483 citing multiple quality system deficiencies. These included inadequate environmental controls and process validation for its clean room, and significant failures in its corrective and preventive action (CAPA) system. The firm also failed to adequately establish complaint handling procedures and did not submit Medical Device Reports (MDRs) within the required timeframes.