St. Jude warning letter
This article was originally published in The Gray Sheet
Executive SummaryPuerto Rico AngioSeal femoral closure device manufacturing facility draws FDA warning letter citing quality system deficiencies detected in a fall 2004 inspection. "We take a warning letter with the utmost seriousness and priority. The warning letter arose from observations of an inspection of one of our plants last year. We responded both to those observations and to the warning letter with energetic corrective actions to address observed deficiencies at a root-cause level to ensure that they will never happen again," CEO Dan Starks remarked during St. Jude's April 21 earnings call. "We're in the process of further follow-up to close the loop with FDA." The letter has no impact on patients or a material impact on the company, he stated...
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