Lupin Ltd. (Unit I) - Dec. 4, 2018
Issue Date
Dec 04, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Krishan C. Sharma
Contact Title
Site Head and Senior Vice President - Manufacturing
Address 1
Unit I, 198-202 New Industrial Area No. 2
City
Mandideep, Madhya Pradesh
Zip/Postal Code
46206
Country
India
Inspection Range
Nov 26, 2018 - Dec 04, 2018
Pages
25
First Observation
Procedures for aseptic process (media fill) simulations, performed in the sterile API manufacturing facility, are not adequate.
Investigator(s): Christopher S. Keating, June P. Page, Unnee Ranjan, and Pratik S. Upadhyay