FDA 483 - Lupin Limited - July 17, 2025

During an FDA inspection conducted from July 7 to July 17, 2025, Lupin Limited, a human drug manufacturer based in Pithampur, India, was cited for multiple deficiencies. The observations highlight significant concerns regarding quality control, complaint handling, and data integrity, indicating non-compliance with Current Good Manufacturing Practices (cGMP).

Key violations included the absence of appropriate identity testing for components, specifically a critical ingredient used in cream manufacturing, impacting multiple batches distributed within the U.S. expiry period. The company also failed to thoroughly investigate 107 customer complaints about difficult-to-open packaging for a specific product. Despite the recurring nature of this issue, Lupin Limited did not determine a root cause or perform confirmatory testing on retained samples.

Furthermore, the inspection revealed serious issues with in-process controls and electronic data management. Lupin Limited"s single, generic standard operating procedure for reviewing electronic audit trails across various computerized systems lacked system-specific details, leading to inconsistent practices and reliance on individual experience. Quality Assurance (QA) personnel lacked independent login access to manufacturing equipment software, depending on IT for audit trail reviews, which compromised their oversight independence. QA also reviewed only printed audit trail copies for batch release, rather than directly accessing the electronic systems. Additionally, critical sample collection parameters, such as exact collection times, were inadequately documented.

Lupin Limited is required to respond to these observations by outlining comprehensive corrective and preventive actions to address all identified deficiencies and ensure full compliance with regulatory standards.