Alembic Pharmaceuticals Ltd. - Nov. 10, 2021
Issue Date
Nov 10, 2021
Region
HQ
Category
Drug
$117.00
Contact Name
Srinivas Avirneni
Contact Title
Head Site Operations
Address 1
Formulation Division Iii, Plot No. 779p/790p, Village - Karakhadi, Taluka-Padra
City
Vadodara, Gujarat
Zip/Postal Code
391450
Country
India
Inspection Range
Oct 28, 2021 - Nov 10, 2021
Pages
25
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of inprocess material and the drug product.
Investigator(s): Yvins Dezan and Kellia N. Hicks