The United States Food and Drug Administration (USFDA) has inspected Aurobindo Pharma's wholly owned subsidiary, APL Health Care's Unit I & III, an Orals (Tablets, Capsules and Soft gel Capsules) and Derma Manufacturing facility located at Jadcherla, Mahabub Nagar District, Telangana, from January 9 to January 18, 2023.
At the end of the inspection, the company has been issued a 'Form 483' with 2 observations. The observations are procedural in nature. The company will respond to the USFDA within the stipulated timelines and work closely with USFDA to close the observations at the earliest.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
