Sandoz Inc. - April 16, 2019
Issue Date
Apr 16, 2019
Region
Southwest
Category
Drug
$117.00
Contact Name
Antony S. Fraij
Contact Title
VP Technical Operations
Address 1
2555 W. Midway Blvd.
City
Broomfield
State
CO
Zip/Postal Code
80020-1632
Country
United States
Inspection Range
Apr 08, 2019 - Apr 16, 2019
Pages
4
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): Erika V. Butler