The US Food and Drug Administration (USFDA) has issued Form 483 with 6 observations to Aurobindo Pharma’s Unit III, a formulation manufacturing facility located at Bachupally in Hyderabad.
The USFDA had conducted an inspection from April 10, 2017 to April 18, 2017. The observations are all on procedural improvements. None of the observations are related to data integrity. The company will be responding as per the prescribed time lines.
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.
