FDA 483 - Aurobindo Pharma Limited - September 05, 2025

A recent FDA inspection conducted at Aurobindo Pharma Ltd., Unit XII, Bachupally, Hyderabad, India, from August 25 to September 5, 2025, identified significant deficiencies in the company"s sterile drug manufacturing processes and quality control systems. This document, an FDA Form 483, details observations that require corrective actions, though it does not represent a final agency determination of compliance. The primary violations centered on the lack of adequate procedures to prevent microbiological contamination of sterile drug products and insufficient validation of aseptic processes. Inspectors observed excessive interventions within the Restricted Access Barrier System (RABS) and non-adherence to established aseptic processing procedures, such as improper sanitization of stopper bags and undocumented interventions during vial sealing operations. Poor aseptic techniques by operators, including blocking "first air" to sterile components and entering Grade A spaces improperly, were also noted. Further issues included inadequate airflow visualization studies that showed turbulent airflow without corresponding dynamic studies, and aseptic process simulations (media fills) that failed to simulate crucial vial sealing activities. Environmental monitoring systems were found deficient, lacking comprehensive viable and non-viable particle monitoring in critical aseptic areas, and personnel monitoring was not consistently followed. Additionally, the firm"s swab method for surface monitoring was deemed unreliable due to inadequate validation. The inspection also highlighted a failure to thoroughly investigate product complaints, such as tablet discoloration, where identified deficiencies in material handling were not adequately considered. Aurobindo Pharma Ltd. is required to address these observations with robust corrective and preventive actions.