The United States Food and Drug Administration (USFDA) conducted an inspection at Aurobindo Pharma’s Unit IV, a formulation manufacturing facility located at Pashamylaram, Hyderabad from February 12, 2018 to February 20, 2018. This is a scheduled inspection and at the end of the inspection, the regulator issued a Form 483 with 9 observations to the company.
None of the observations are related to data integrity or repetitive in nature. The company is in the midst of providing a comprehensive response to the observations and would be replying to the USFDA within 15 working days from the date of closure (i.e. February 20, 2018) of audit.
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.
