Fresenius Kabi USA, LLC - Oct. 13, 2023
Issue Date
Oct 13, 2023
Region
Northeast
Category
Drug
$117.00
Contact Name
Anthony J. Giessert
Contact Title
Vice President, Quality Assurance, Business Unit Generics & I. V. Fluids NAM
Address 1
3159 Staley Rd.
City
Grand Island
State
NY
Zip/Postal Code
14072-2028
Inspection Range
Oct 04, 2023 - Oct 13, 2023
Pages
5
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Investigator(s): Jazmine N. Brown and Mindy M. Chou