Issued: 3/8/12
Region: Southwest
Category: Drug 483s
Inspection date range: 2/27/12-3/8/12
Pages: 7
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.
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