Intas Pharmaceuticals, Ltd. - July 3, 2015
Issue Date
Jul 03, 2015
Region
HQ
Category
Drug
$117.00
Contact Name
Satakarni Makkapati
Contact Title
Senior Vice President - Biopharma Operations
Address 1
Plot No. 423/P/A
Address 2
Sarkhej-Bavla Highway
City
Moraiya, Ta: Sanand
State
Ahmedabad
Zip/Postal Code
382 214
Country
India
Inspection Range
Jun 22, 2015 - Jul 03, 2015
Pages
16
First Observation
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
Investigator(s): Ralph M. Bernstein, Reyes Candau-Chacon, Lakshmi R. Narasinham, Leslie A. Rivera-Rosado, and Daniel J. Roberts