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Ansell Xtra Pleasure condoms lacked 510(k)s, had GMP problems -- warning letter.

This article was originally published in The Tan Sheet

Executive Summary

ANSELL XTRA PLEASURE CONDOMS LACK OF 510(k) CITED IN WARNING LETTER June 8 from FDA. A 510(k) clearance is "necessary because this device is significantly changed in design from devices that [Ansell] previously had in commercial distribution, and this change could significantly affect the safety or effectiveness of the device," the warning letter states. The company acknowledged it did not seek premarket clearance prior to introducing the LifeStyles Xtra Pleasure condom in the U.S. late in November.

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