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Ansell's Malaysian glove facility awaits FDA reinspection to confirm GMP compliance.

This article was originally published in The Gray Sheet

Executive Summary

ANSELL'S MALAYSIAN GLOVE FACILITY AWAITING FDA REINSPECTION following the company's steps to correct good manufacturing practices deficiencies identified by FDA. Ansell-Perry, which owns the facility and is a subsidiary of Ansell Healthcare, says it is working with the agency to set a date for reinspection, which is needed to confirm the facility's GMP compliance. The facility's latex surgical and exam gloves have been on import detention since November 3, 1995 due to GMP violations.

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