Teva Parenteral Medicines, Inc. - Aug. 20, 2021
Issue Date
Aug 20, 2021
Region
Pacific
Category
Drug
$117.00
Contact Name
Richard Pickup
Contact Title
Site General Manager
Address 1
19 Hughes
City
Irvine
State
CA
Zip/Postal Code
92618-1902
Country
United States
Inspection Range
Jul 21, 2021 - Aug 20, 2021
Pages
25
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Amir Alavi, Thomas J. Arista, Bryan A. Galvez, Santiago Gallardo Johnson, Sangeeta M. Khurana, and Walden H. Lee