Novel Laboratories, Inc. dba Lupin Pharmaceuticals - Nov. 5, 2020
Issue Date
Nov 05, 2020
Region
Central
Category
Drug
$117.00
Contact Name
Ronald W. Overhiser
Contact Title
Vice President - Operations and Site Head
Address 1
400 Campus Dr.
City
Somerset
State
NJ
Zip/Postal Code
08873-1145
Country
United States
Inspection Range
Sep 10, 2020 - Nov 05, 2020
Pages
38
First Observation
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent
malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Investigator(s): Saleem A. Akhtar, Lata C. Mathew, Ko U. Min, and Unnee Ranjan