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Snapshot: 2015 Medical Device Quality-Related Warning Letters

This article was originally published in The Gray Sheet

Executive Summary

A "Gray Sheet" analysis has discovered that the industry racked up its fewest number of FDA quality-related warning letters in nearly a decade. The agency released 74 warning letters to its website in calendar year 2015 that included at least one quality system violation. Other findings: letters to foreign firms is down; CAPA is the most-oft cited violation; and close-out letters hit a new peak. And check out our infographic, which includes a listing of where non-US letters went last year and a breakdown of other data.






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