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Domestic, Foreign Manufacturers Achieve Virtual Quality-Related FDA Warning Letter Parity; Missive-Counting Methodologies Explained

This article was originally published in The Gray Sheet

Executive Summary

Quality-related warning letters sent to foreign device manufacturers are on the rise, FDA data shows: 62 domestic and 59 non-US firms received letters that included at least one violation of the Quality System Regulation. Also: FDA's yearly warning letter count has closely mirrored separate analyses by The Gray Sheet for more than a decade, yet over the past two years those counts have wildly diverged; we explain why.

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