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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...

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Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
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DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
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More from Policy & Regulation

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 
• By Brian Bossetta

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
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June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
• By Amanda Maxwell

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.