FDA 483 - Pharmaron (Ningbo) Technology Development Co., Ltd. - November 01, 2024

An FDA inspection of Pharmeron (Ningbo) Technology Development Co. Ltd., an API manufacturer in Ningbo, China, revealed significant deficiencies in quality control. Observations included a lack of growth promotion testing for microbiological media, inadequate environmental monitoring in processing areas, and insufficient written procedures for raw material sampling. These issues indicate a failure to ensure drug product quality and compliance with manufacturing standards.