Fresenius Kabi USA, LLC - Feb. 2, 2024
Issue Date
Feb 08, 2024
Region
Southeast
Category
Device
$117.00
Contact Name
Jean Georoes Michael Allaume
Contact Title
Plant Manager
Address 1
5200 Corporate Parkway
City
Wilson
State
NC
Zip/Postal Code
27893
Inspection Range
Jan 30, 2024 - Feb 08, 2024
Pages
5
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Inga M. Warr