The United States Food and Drug Administration (US FDA) has inspected the Unit IV, a Formulation manufacturing facility, of APL Healthcare, a wholly owned subsidiary of Aurobindo Pharma, situated at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh, from September 13 to September 19, 2023. At the end of the inspection, a ‘Form 483’ was issued with 1 observation which is procedural in nature.
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.
