Puretek Corp. - March 18, 2015
Issue Date
Mar 18, 2015
Region
Pacific
Category
Drug
$117.00
Contact Name
Abul K. Bhuiyan
Contact Title
Sr. Vice President & Chief Scientific Officer
Address 1
1145 Arroyo St.
Address 2
Ste. D
City
San Fernando
State
CA
Zip/Postal Code
91340-1820
Country
United States
Inspection Range
Mar 04, 2015 - Mar 18, 2015
Pages
3
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): Saied A. Asbagh, Greg K. Keshishyan, and Uttaniti Limchumroon