US Pharmaceuticals, Inc. - Dec. 18, 2018
Issue Date
Dec 18, 2018
Region
Central
Category
Drug
$117.00
Contact Name
Jitendra R. Patel
Contact Title
VP of Production and Operations
Address 1
681 Main St.
Address 2
Ste. 27
City
Belleville
State
NJ
Zip/Postal Code
07109-3471
Country
United States
Inspection Range
Oct 31, 2018 - Dec 18, 2018
Pages
8
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): Monika Borkowska and Guerlain Ulysse