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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Baxter warning letter: Firm's Renal division, maker of HomeChoice peritoneal dialysis systems, MiniCaps disconnect caps and transfer sets, and Xenium dialyzers, is cited in a June 3 1warning letter for failing to comply with Medical Device Reporting and Quality System regulations. Baxter's internal systems do not assure timely identification and evaluation of potential MDR events, and the firm failed to submit MDR reports within the required 30-day window, FDA said. In addition, the company's corrective and preventive action procedures were found lacking. Baxter has received nine device-related warning letters since 1997, according to FDA's warning letter database
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