The US Food and Drug Administration (USFDA) has decided that the inspection classification of Aurobindo Pharma’s injectable formulation manufacturing facility at Hyderabad is voluntary action indicated (VAI). As per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.
The inspection of Unit IV at Hyderabad, an injectable manufacturing formulation facility of the company, was conducted between November 4-13, 2019 by the USFDA.
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.
