Fresenius Medical Care, North America - Aug. 13, 2020
Issue Date
Aug 13, 2020
Region
Southwest
Category
Device
$117.00
Contact Name
Brett A. Barton
Contact Title
Senior Director of Manufacturing Operations
Address 1
475 W. 13th St.
City
Ogden
State
UT
Zip/Postal Code
84404-5554
Country
United States
Inspection Range
Aug 05, 2020 - Aug 13, 2020
Pages
3
First Observation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Investigator(s): Nayan J. Patel