Aurobindo Pharma Ltd – FDA 483, Dec 14, 2018

An FDA inspection conducted at Aurobindo Pharma Limited - Unit IV, located in Medak District, Hyderabad, Telangana, India, from December 3 to December 14, 2018, identified significant concerns regarding the manufacturing of sterile human drug products. The primary issues, detailed in a Form FDA 483, centered on the company's inadequate procedures to prevent microbiological contamination, a critical aspect of Current Good Manufacturing Practices (CGMP). Key violations included deficiencies in environmental monitoring, such as insufficient collection of air and surface samples in critical aseptic processing areas and improper placement of monitoring plates. Smoke studies, intended to demonstrate unidirectional airflow and aseptic practices, were found to be incomplete or unrepresentative of actual operating conditions. Furthermore, simulations of interventions during media-fill runs did not accurately reflect routine aseptic filling operations in terms of frequency, duration, or documentation. The inspection also noted inadequate sanitization procedures for equipment and primary packaging components, and a lack of adherence to established aseptic intervention guidelines. Additionally, an operator was observed with exposed skin due to improperly worn protective apparel, posing a direct contamination risk. Aurobindo Pharma Limited is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards for sterile drug manufacturing.