The United States Food and Drug Administration (USFDA) inspected Aurobindo Pharma Limited, wholly owned subsidiary, APL Healthcare Limited Unit I & III, an Orals (Tablets, Capsules and Soft gel Capsules) and Derma Manufacturing facility located at Jadcherla, MahabubNagar District, Telangana, from January 9-18, 2023.

At the end of the inspection, the company has been issued ‘Form 483’ with two observations. The observations are procedural in nature and the company will respond to the USFDA within the stipulated timelines and work closely with USFDA to close the observations at the earliest.