Warning Letters And Close-Outs – May 2023
The US FDA issued one warning letter last month, and closed out warnings previously issued to Centurion Medical, Mentor Worldwide and Unimicro Medical Systems.
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A handful of domestic and foreign manufacturers were dinged by the US FDA for problems with quality systems. The agency released five device-related warning letters last month.
In the only device-related warning letter released by the US FDA this week, Centurion Medical Products Corp. – a maker of sterile convenience kits – was cited for quality systems and premarket violations. The agency in its letter also voiced sterility concerns.
Two makers of breast implants failed to comply with years-old FDA post-approval study orders, and TEI Biosciences Inc. – an Integra LifeSciences company – ran afoul of the US agency's Quality System Regulation in device-related warning letters released by FDA this week.