FDA Warns Fresenius After Puerto Rico Plant Inspection

Law360, New York (August 23, 2013, 4:04 PM EDT) -- Fresenius Kabi AG on Friday disclosed receiving a warning letter this month from the U.S. Food and Drug Administration over problems with its labeling and responses to complaints at a Puerto Rico manufacturing plant, marking at least the third admonition this year for the dialysis firm.

The letter concerned production of blood transfusion bags by Fresenius subsidiary Fenwal Inc. and stemmed from an April inspection in which FDA investigators uncovered violations "primarily related to complaint-handling procedures, labeling issues and filing of field alerts not in accordance...
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