Aurobindo Pharma gets US FDA inspection report for Pashamylaram unit1 min read . Updated: 19 Feb 2020, 11:19 AM IST
- The US FDA had inspected the pharmaceutical company’s unit during 4-13 November
- The company had received Form 483 with 14 observations
New Delhi: Aurobindo Pharma Ltd on Wednesday said it has received Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for Unit IV of its general injectable formulation manufacturing facility in Pashamylaram, Hyderabad.
The drug maker did not disclose the details of the US FDA report in its regulatory filing.
The US FDA had inspected the pharmaceutical company’s unit during 4-13 November, and issued Form 483 with 14 observations after the inspection, according to a 13 November regulatory filing by the pharma company.
Form 483 is issued to management of a company to conclude an inspection when an investigator observes conditions that may be in violation of US FDA regulations under its Food Drug and Cosmetic (FD&C) Act and related Acts, according to the US regulator’s definition available on the website.
“Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously," US FDA said on its website.
“We believe that none of these observations are related to data integrity issues. The company will respond to the US FDA within the stipulated timeline," the company had informed stock exchanges on 13 November.
Shares of Aurobindo Pharma surged 17.6% to ₹588.05 on the BSE today, in line with broader market where Sensex was up 0.58% at 41,132.14 points.