The United States Food and Drug Administration (USFDA) has inspected Aurobindo Pharma’s Unit III, a Formulation manufacturing facility situated at Bachupally Village, Medchal Malkajgiri District, Telangana, from July 14, 2023 to July 21, 2023.
At the end of the inspection, the company has been issued a ‘Form 483’ with 3 observations. The observations are procedural in nature. It will respond to the USFDA within the stipulated timelines and work closely with US FDA 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.
