FDA 483 - Remel Cleveland, a Division of Remel Inc. - November 20, 2019

An FDA inspection of Rem I, Inc. in Oakwood Village, OH, a medical device specification developer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, including trending, investigation thresholds, and verification of effectiveness. Additionally, complaint handling procedures were found to be inadequate, with issues such as missing complaints, unassigned cause codes, and insufficient investigation justifications.