FDA 483 - Elementis Specialties (India) Private Limited - September 20, 2024

During an inspection conducted from September 16-20, 2024, Elementis Specialties (India) Private Limited, an Active Pharmaceutical Ingredient (API) manufacturer, received an FDA Form 483 citing significant observations regarding its manufacturing and laboratory control systems. The inspection revealed several critical issues. First, the company failed to establish adequate data and written procedures for production and process controls. Specifically, there was a lack of process validation data to ensure the consistent manufacturing of several APIs, impacting their identity, strength, purity, and quality. Second, the long-term stability program for APIs was deemed inadequate. Stability samples were stored without proper temperature and humidity monitoring, and their packaging did not represent the actual commercial configuration of the final products. Third, the firm demonstrated insufficient controls over computer systems used for laboratory records. The quality unit did not routinely review raw data and audit trails from essential analytical software. Furthermore, the quality manager held administrative privileges allowing for manual data manipulation and deletion, and audit trails showed undocumented aborted sample injections. These observations highlight a need for Elementis Specialties to implement comprehensive corrective actions to comply with regulatory standards for manufacturing and quality control of pharmaceutical ingredients. The firm must ensure robust process validation, establish adequate stability programs, and reinforce data integrity controls across its laboratory operations.