Novel Laboratories, Inc. - Dec. 21, 2018
Issue Date
Dec 21, 2018
Region
Central
Category
Drug
$117.00
Contact Name
Kurt R. Neilsen
Contact Title
President
Address 1
400 Campus Dr.
City
Somerset
State
NJ
Zip/Postal Code
08873-1145
Country
United States
Inspection Range
Dec 03, 2018 - Dec 21, 2018
Pages
14
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): Jogy George and Lata C. Mathew