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

An FDA inspection of Merck Life Science Technologies (Nantong) Co. Ltd, an excipients and API manufacturer in Nantong, China, revealed significant quality control deficiencies. Observations included inadequate investigations into customer complaints and deviations, a lack of procedures to prevent microbiological contamination of non-sterile products, and failures in the stability testing program and material sampling criteria.