Milan Laboratories (India) Pvt., Ltd. - Aug. 4, 2017
Issue Date
Aug 04, 2017
Region
HQ
Category
Drug
$117.00
Contact Name
Rohini Dongre
Contact Title
Plant Director
Address 1
Plot 63,64,65,67,35,36,87 J.C. I.E. Ltd.
Address 2
Kamcthe, Panvel, Raigad
City
Navi Mumbai, Maharashtra
Zip/Postal Code
410209
Country
India
Inspection Range
Jul 31, 2017 - Aug 04, 2017
Pages
3
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Felix Maldonado