FDA Hits Fresenius AG With 3rd Warning Letter This Year

Published: Aug 27, 2013

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The FDA hands German healthcare group Fresenius a warning letter over violations cited after an April inspection of a Puerto Rico facility. The FDA took issue with certain manufacturing processes at a Fresenius (NYSE:FMS) plant in Puerto Rico, handing the German medical healthcare company its 3rd warning letter this year. Following an April inspection the FDA raised concerns about product labeling and complaint-handling processes at the blood bag manufacturing plant, but said the problems did not lead to any cases of patient harm.

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