Zimmer Warning Letter Confirms Ongoing Issues With CAPA, Process Validation
US FDA has released a six-violation warning letter sent to a Zimmer Biomet facility in Warsaw, Ind. The company had already acknowledged that the letter was a possibility.
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Zimmer Biomet reported Q4 results that reflected solid progress in the company’s turnaround efforts, with knees leading the charge. But the company is making slower-than-expected progress resolving FDA warning letter issues and faces a new bribery lawsuit in Mexico.
Zimmer Biomet’s net sales were up 1.2% year-over-year in the second quarter. CEO Bryan Hanson said the ROSA Knee robotic surgery system is performing even better than expected since it launched earlier this year, and is expected to be an important revenue-driver in the future.
Zimmer Biomet dinged for quality systems violations in the only device-related warning letter released by US FDA this week.