Aurobindo Pharma Ltd. - May 10, 2022
Issue Date
May 10, 2022
Region
HQ
Category
Drug
$117.00
Contact Name
Mettu Madan Mohan Reddy
Contact Title
Director
Address 1
Unit Vii, Formulation Plant , Plot S- 1
Address 2
Survey 411, 425, 434 - 435, 458, Tsiic, Green Ind. Park
City
Polepally, Mahaboob Nagar
State
Telangana
Zip/Postal Code
509302
Country
India
Inspection Range
May 02, 2022 - May 10, 2022
Pages
13
First Observation
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet
any of its specifications did not extend to other batches of the same diug product and other drug
products that may have been associated with the specific failure or discrepancy.
Investigator(s): Justin A. Boyd and Darren S. Brown