Category: Drug 483s
Inspection date range: 2/27/12-3/8/12
Company: Fresenius Medical Care, North America
475 W. 13th St.
Ogden, UT 84404-5554
Inspector(s): Erika V. Butler, Kimberley A. Buytaert-Hoefen
Observations: There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.