FDA 483 - Piramal Pharma Limited - March 17, 2025

An FDA inspection conducted at Piramal Pharma Limited's API manufacturing facility in Navi Mumbai, Maharashtra, India, from February 11-17, 2025, revealed several significant concerns regarding adherence to manufacturing quality standards. The inspection report, known as an FDA Form 483, outlined multiple deviations from regulatory expectations, primarily impacting the firm's quality, facilities, production, and materials management systems.Key observations included deficiencies in quality control unit procedures, such as an unattended liquid leak from processing equipment and a lack of proper documentation for operations and equipment checks. The facility also failed to adequately investigate and acknowledge critical alarms from API processing software, indicating potential risks to product quality and process control. Investigations into manufacturing deviations and customer complaints were found to be insufficient, lacking comprehensive follow-up, stability evaluations for affected batches, and proper testing of retained samples. Furthermore, cleaning procedures for shared manufacturing equipment were not validated, and a torn foreign material was found inside a vessel documented as clean. Master production records contained incomplete instructions and prevented adequate documentation of critical processing steps. Critically, temperature-sensitive key starting materials were received at room temperature, compromising their quality, and foreign matter was discovered within an API batch. Piramal Pharma Limited is required to respond to these observations with detailed corrective actions to ensure their processes, procedures, and facilities align with established Good Manufacturing Practices to safeguard the quality and integrity of their active pharmaceutical ingredients.