FDA 483 - Pharmaron Shaoxing Co., Ltd - June 04, 2025

Pharmaron Shaoxing Co., Ltd., an API manufacturer in Shaoxing, China, was cited for significant deficiencies during an FDA inspection. Observations included inadequate Out of Specification investigations, failure to maintain backup files for computerized data, and insufficient cleaning records for manufacturing equipment. These issues indicate a lack of robust quality control and data integrity practices.