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

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

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Record Details

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.

Company: Merck Life Science Technologies (Nantong) Co., Ltd.
Inspection Date: March 14, 2025
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Jose M. Cayuela

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ID · 7a4891fd-9b7e-44c7-86d6-48d40ff4ec8b