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FDA hits Fresenius with 3rd warning letter this year

Tue, 08/27/2013 - 8:59am
Mass Device

The FDA hands German healthcare group Fresenius a warning letter over violations cited after an April inspection of a Puerto Rico facility.

FDA hits Fresenius with 3rd warning letter this year

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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