Zimmer Biomet Warning Letter Posted

FDA has released an 8/24 Zimmer Biomet Warning Letter that the company disclosed last week (see story). The letter notes that the inspection, which was a follow-up to a 2016 inspection at the firm’s Warsaw, IN device manufacturing facility, “revealed continuing, significant violations of the quality system regulations.”

The inspection found that the facility had failed to establish and maintain procedures for verifying or validating the corrective and preventive action, to ensure that such action is effective and does not adversely affect finished devices. The firm also failed to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated. Additionally, it failed to develop, conduct, control and monitor production processes to ensure that devices conform to their specifications, including the monitoring and control of process parameters and device characteristics during production.