Latest FDA Warning Letter

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: 

Zimmer Biomet, Warsaw, IN (8/24): FDA re-inspected the firm in April as a follow-up to a 2016 inspection and found “continuing, significant violations of the quality system regulations.” For example, 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 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.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm618429.htm