Xellia Pharmaceuticals USA, LLC - Dec. 15, 2022
Issue Date
Dec 15, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Jurij Silecky
Contact Title
Director, Quality Assurance
Address 1
200 Northfield Rd.
City
Bedford
State
OH
Zip/Postal Code
44146-4642
Inspection Range
Nov 28, 2022 - Dec 15, 2022
Pages
5
First Observation
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Investigator(s): Lisa R. Hilliard, Vaishali J. Patel, and Nibin Varghese