FDA 483 - Zhejiang Poly Pharm. Co., Ltd - November 08, 2024

Zhejiang Poly Pharm. Co., Ltd, a drug product manufacturer in Linping, China, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written procedures for production and process controls, failure to validate processes for US-bound products, and inadequate equipment cleaning and data integrity controls. These issues indicate a serious lack of adherence to cGMP regulations.