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Zimmer Warning Letter Confirms Ongoing Issues With CAPA, Process Validation

 
• By Elizabeth Orr

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.

Vintage inscription made by old typewriter, warning

US FDA found ongoing concerns during an April inspection of a Zimmer Biomet facility in Warsaw, Ind., a warning letter posted to the agency’s website on Aug. 28 confirmed.

This is the second warning letter Zimmer has received concerning the North Campus plant in recent years. The facility first came to FDA’s attention in 2016, when agency investigators documented 14 separate observations related to quality systems issues in a 58-page FDA Form-483

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