Novartis Gene Therapies, Inc. - June 16, 2021
Issue Date
Jun 16, 2021
Region
Central
Category
Device
$117.00
Contact Name
Sergio Cerdas
Contact Title
Vice President, Manufacturing Operations and Site Head
Address 1
1940 Usg Dr.
City
Libertyville
State
IL
Zip/Postal Code
60048-5346
Country
United States
Inspection Range
Jun 08, 2021 - Jun 16, 2021
Pages
5
First Observation
Deviations from written specifications and laboratory mechanisms are not recorded and justified.
Investigator(s): Lewis K. Antwi, Steven E. Bowen, and Jacqueline M. Diaz Albert