FDA 483 - Merck Life Science Technologies (Nantong) Co., Ltd. - March 14, 2025

An FDA inspection conducted from March 10-14, 2025, at Merck Life Science Technologies (Nantong) Co. Ltd in China, an excipients and API manufacturer, revealed significant deficiencies. The inspection focused on ensuring adherence to regulatory standards governing pharmaceutical manufacturing. Key observations highlighted a systemic failure in the firm's quality control processes. Specifically, the company did not thoroughly investigate unexplained discrepancies or batches failing specifications. This was evidenced by numerous customer complaints from 2023-2025 regarding particulate contamination and endotoxins, where root causes were not identified, reserve samples were not evaluated, and corrective/preventive actions were not established. Furthermore, the company's complaint management procedure was found inadequate, and a foreign material deviation was not properly investigated. Additional issues included the absence of adequate procedures to prevent microbiological contamination for non-sterile products, particularly concerning the transfer of laboratory samples. The stability program for API products was deficient, as it failed to ensure testing in the same container-closure system used for marketing. Lastly, the criteria for determining the amount of material taken for testing were insufficient, lacking consideration for material criticality, variability, or supplier history. These observations indicate non-compliance with Good Manufacturing Practices (GMP) and necessitate prompt, comprehensive corrective and preventive actions from Merck Life Science Technologies (Nantong) to address these quality system breakdowns and ensure product quality and patient safety.