Nesher Pharmaceuticals, LLC - July 31, 2019
Issue Date
Jul 31, 2019
Region
Southwest
Category
Drug
$117.00
Contact Name
Kalwinder S. Bolla
Contact Title
Senior Director of Operations
Address 1
13910 Saint Charles Rock Rd.
City
Bridgeton
State
MO
Zip/Postal Code
63044-3826
Country
United States
Inspection Range
Jul 29, 2019 - Jul 31, 2019
Pages
2
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): Bei Y. He and Wayne D. McGrath