Novel Laboratories, Inc. dba Lupin Somerset - Jan. 13, 2023
Issue Date
Jan 13, 2023
Region
Central
Category
Drug
$117.00
Contact Name
Ronald W. Overhiser
Contact Title
Vice President of Operations, Site Head
Address 1
400 Campus Dr.
City
Somerset
State
NJ
Zip/Postal Code
08873-1145
Inspection Range
Jan 04, 2023 - Jan 13, 2023
Pages
4
First Observation
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, inprocess materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Investigator(s): Karishma G. Gopaul, David A. Oluwo, and Janet A. Rajan