Amphastar Pharmaceuticals, Inc. - August 8, 2014
Issue Date
Aug 12, 2014
Region
Pacific
Category
Drug
$117.00
Contact Name
Yongfeng Zhang
Contact Title
CEO
Address 1
11570 6th St.
City
Rancho Cucamonga
State
CA
Zip/Postal Code
91730-6025
Country
United States
Inspection Range
Jul 09, 2014 - Aug 08, 2014
Pages
10
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): Carla J. Lundi