FDA 483 - Fresenius Medical Care Holdings, Inc. - August 02, 2019

An FDA inspection of Fresenius Medical Care Holdings, Inc.'s Corporate Headquarters in Waltham, MA, revealed significant deficiencies in adverse drug experience reporting. The firm failed to report several serious and unexpected adverse drug experiences to the FDA within the required 15-day timeframe. Additionally, the company submitted Individual Case Safety Reports (ICSRs) that omitted critical adverse drug experience terms.