FDA 483 - Lupin Limited - May 19, 2017

An FDA inspection conducted at Lupin Limited's Pithampur facility from May 8-19, 2017, identified significant deficiencies in their manufacturing and quality control systems, leading to an FDA Form 483. A critical observation was the firm's failure to thoroughly investigate Out-of-Specification (OOS) results, with approximately 96% of OOS findings over two years being invalidated. These invalidations were frequently attributed to recurring human errors, such as solution preparation, dilution, and sample contamination, without adequate corrective actions being implemented.

Further issues included incomplete OOS investigation records, where identified root causes for material hold times contradicted statements from management. The company also lacked adequate written procedures for essential production and process controls, particularly concerning hold time studies that utilized unrepresentative sample sizes. Batch production records were found deficient, missing identification and second-person verification for significant operational steps in aseptic processes. Equipment qualification was questioned due to stability chambers lacking comprehensive temperature uniformity data, relying only on fixed probes. Lastly, the firm had not established written procedures for the cleaning and maintenance of critical equipment, specifically failing to verify the functionality of a backup system for a sterile product storage tank. These observations indicate non-compliance with current Good Manufacturing Practices, requiring comprehensive corrective actions from Lupin Limited to ensure drug product quality and regulatory adherence.