FDA 483 - Lupin Limited - September 08, 2025

An FDA inspection conducted between September 8 and September 16, 2025, at Lupin Limited"s sterile manufacturing facility in Nagpur, Maharashtra, India, revealed significant deficiencies in processes designed to prevent microbiological contamination of sterile drug products. The observations outlined in the FDA Form 483 document highlight inadequate validation of aseptic and sterilization procedures. Specifically, the facility"s qualification of airflow in critical aseptic areas was deemed insufficient, with smoke studies failing to accurately assess unidirectional flow and contamination risks due to various technical issues. Furthermore, sterilization load patterns were inadequately validated, lacking proper risk assessments for biological indicator placement and failing to simulate worst-case conditions for various components. Personnel aseptic qualification also presented shortcomings, with unclear roles and a failure to track all required interventions during media fills, which was not retrospectively evaluated. Qualification studies for equipment decontamination were found deficient, lacking risk assessments to identify challenging conditions created by complex geometries and undefined "minimum touch" criteria. Additionally, initial qualifications for new container sizes on various lines did not include all necessary interventions in executed batches. The inspection also noted that procedures to prevent microbiological contamination were not consistently established, written, or followed, as interventions during commercial manufacturing were not tracked by container size, hindering the detection of specific issues. These observations necessitate comprehensive corrective actions to ensure compliance with good manufacturing practices and safeguard the sterility assurance of drug products.