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Guidance on imports of faulty condoms, medical gloves

This article was originally published in The Gray Sheet

Executive Summary

FDA releases two final guidance documents July 11 outlining a risk-based strategy for dealing with manufacturers' imports of 1condoms and of 2medical gloves that repeatedly do not meet FDA's quality criteria. CDRH says some foreign manufacturers and shippers attempt to import condoms and medical gloves that fail water leak testing, putting users at risk. The agency will place manufacturers of faulty condoms or medical gloves into a two-year, three-tiered import surveillance and detention cycle. If the firm reaches final Level 3 detention within the 24 months, FDA may refuse import. The documents finalize 2000 draft guidance
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