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FDA Warning Letters Released The Week Of Sept. 27

This article was originally published in The Gray Sheet

Executive Summary

The following chart lists medical-device-related warning letters recently released by FDA. If an inspection led to the warning letter, the location of the inspected facility and dates of inspection are noted; otherwise, the location of the warning letter recipient or Web site address and date of review is listed. Violations cited by FDA are categorized as follows: quality system regulation (QSR) deficiencies ? medical device reporting violations (MDR) ? pre-market violations, such as failure to obtain a 510(k) for a device modification or to have a pre-market approval application in effect ? clinical investigator infractions ? and registration and listing violations (R&L).

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