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Device center warning letter volume

This article was originally published in The Gray Sheet

Executive Summary

Almost triples in FDA's fiscal 1992 (year ended Sept. 30), according to figures from the center's office of compliance and surveillance. During FY 1992, 464 warning letters were issued, compared to 168 warning letters sent out in FY 1991. OCS approved 10 injunctions during FY 1992 (versus seven in FY 1991); 52 seizures, down from 67 in the prior fiscal year; two citations, compared to three in FY 1991; and three prosecutions, down from four in the year-ago period. The device center also recommended one civil penalties case in FY 1992; the action currently is pending at the agency level....
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