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On August 24, 2018, Zimmer Biomet received a Warning Letter from the FDA regarding quality violations found during 2016 and 2018 inspections at a facility in Warsaw, IN.
The FDA inspected Zimmer Biomet’s North Campus manufacturing facility in 2016, documenting a number of violations in Form 483. Although Zimmer Biomet responded about how it would address the issues, a re-inspection in April of this year resulted in another Form 483.
The August Warning Letter, triggered from the April re-inspection, cites “our recent inspection revealed continuing significant violations of the quality system regulations.”
The Warning Letter addressed several of the violations Zimmer Biomet was cited for, including, but not limited to:
Failure to establish and maintain procedures for verifying or validating a corrective and preventive action.
“During the inspection, review of three separate CAPA’s revealed that your firm has not been able to demonstrate that the corrective or preventive actions taken by your firm are effective in ensuring that devices being distributed meet all finished product specifications. … We are concerned about your firm’s ability to verify the effectiveness of the corrective actions included in this CAPA, when errors are not being identified in your interim processes.”
Failure to develop, conduct, control and monitor production processes to ensure that a device confirms to its specifications, including the monitoring and control of process parameters and device characteristics during production.
“During the inspection, we observed five separate operations in which employees on the production line were not following production procedures adequately.”
All five of these obervations are addressed within the Warning Letter.
Problems were also found with the North Campus facility’s design validation processes, its handling of non-conformance reports and its CAPA implementation.
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