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FDA INSPECTION OF 30 PAKISTANI SURGICAL INSTRUMENT MANUFACTURERS

This article was originally published in The Gray Sheet

Executive Summary

FDA INSPECTION OF 30 PAKISTANI SURGICAL INSTRUMENT MANUFACTURERS has resulted in at least 19 warning letters to inspected firms in the past two months. In 15 letters released the week of May 9 ("The Gray Sheet" May 16, I&W-11), as well as two released the week of April 11 ("The Gray Sheet" April 18, I&W-7) and two released the week of March 28 ("The Gray Sheet" April 4, I&W-9), FDA cites the firms for good manufacturing practice violations. Although several inspection reports are still under review, FDAers say it is expected that all 30 inspected firms will receive warning letters.
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