FDA 483 - Aurobindo Pharma Ltd - May 24, 2019

Aurobindo Pharma Ltd in Medchal, India, received a Form 483 with 10 observations during an inspection from May 13-24, 2019. The observations highlight significant deficiencies in quality control, data integrity, equipment cleaning, complaint handling, and computer system controls, indicating a lack of adherence to cGMP regulations. These issues raise concerns about the quality and reliability of drug products manufactured at the facility.