http://www.pharmaceuticalproductguide.com/blog A comprehensive guide to pharmaceutical products for medical professionals Fri, 11 Jun 2010 09:15:33 +0000 http://wordpress.org/?v=2.8.2 en hourly 1 http://www.pharmaceuticalproductguide.com/blog/2008/05/13/fda-warning-letter-to-baxa/ http://www.pharmaceuticalproductguide.com/blog/2008/05/13/fda-warning-letter-to-baxa/#comments Tue, 13 May 2008 17:25:18 +0000 Kimberly O'Brien http://www.pharmaceuticalproductguide.com/blog/2008/05/13/fda-warning-letter-to-baxa/ Baxa has been issued a warning letter by the FDA for failing to report two complaints in which the patients suffered serious injuries due to incorrect concentration administration of solutions caused by user error. The medical device reporting (MDR) requirements are very specific on the need for such events being reported.

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