Intas Pharmaceuticals, Ltd. - Aug. 2, 2019
Issue Date
Aug 02, 2019
Region
HQ
Category
Drug
$117.00
Contact Name
Kirti B. Maheshwari
Contact Title
Chief Technical Officer
Address 1
458 191 218 Plot No. 457
City
Ahmedabad
State
Gujarat
Zip/Postal Code
382210
Country
India
Inspection Range
Jul 22, 2019 - Aug 02, 2019
Pages
26
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Investigator(s): Thomas J. Arista and Rita K. Kabaso