Qualgen, LLC - May 10, 2017
Issue Date
May 10, 2017
Region
Southwest
Category
Drug
$117.00
Contact Name
Shaun P. Riney
Contact Title
General Manager
Address 1
14844 Bristol Park Blvd.
City
Edmond
State
OK
Zip/Postal Code
73013-1891
Country
United States
Inspection Range
Apr 17, 2017 - May 10, 2017
Pages
5
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): Margaret M. Annes