Abbott Abbokinase
Executive Summary
Additional manufacturing deficiencies found during inspections of Abbott and the company's supplier of human kidney cells, BioWittaker, FDA said in a July 16 "Talk Paper." FDA has sent a letter to Abbott identifying "numerous significant deviations from current good manufacturing practices." Abbott may not distribute Abbokinase (urokinase) until the company completes investigations of reovirus and mycoplasm contamination, including the source of human kidney cells and validates manufacturing processes. The agency conducted the inspections after a January letter to health care professionals alerting physicians of the risk of transmitting infectious agents (1"The Pink Sheet" March 22, In Brief)