Bachem Americas, Inc. - March 27, 2023
Issue Date
Mar 27, 2023
Region
Pacific
Category
Drug
$117.00
Contact Name
Rohtash Kumar
Contact Title
Vice President and Site Manager
Address 1
1271 Avenida Chelsea
City
Vista
State
CA
Zip/Postal Code
92081-8315
Inspection Range
Mar 20, 2023 - Mar 27, 2023
Pages
6
First Observation
There is evidence of a failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.
Investigator(s): Cecilia H. Kieu