United States Food and Drug Administration (USFDA) has concluded inspection at Aurobindo Pharma’s unit - IX, an intermediate facility situated at Gundlamachnoor Village, Telangana. USFDA has inspected the said facility from November 10 to November 18, 2022. At the end of the inspection, the Company has been issued a ‘Form 483’ with 10 observations.
In company’s view, these observations are procedural in nature and not related to data integrity. The Company will respond to the US FDA, within the stipulated timeline and shall work closely with the agency to address 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.
