China NMPA Inspection - Baiyun Dongtai Shangqiu Pharmaceutical Co., Ltd. - June 07, 2016

Baiyunshan Dongtai Shangqiu Pharmaceutical Co., Ltd. faced an unannounced inspection by the State Food and Drug Administration and the Henan Provincial Food and Drug Administration from April 14-16, 2016, following a complaint. The inspection revealed critical violations of the "Drug Administration Law of the People's Republic of China" and Good Manufacturing Practice (GMP) regulations.

Primary issues included a significantly deficient audit of their sole artificial bezoar raw material supplier, Shangqiu Tianxiang Biotechnology Co., Ltd., which operated from Baiyunshan Dongtai’s own rented facilities. The audit failed to assess crucial aspects such as production facilities, environment, and quality management, indicating a severe lack of supplier oversight. Further findings confirmed the supplier’s rudimentary, unsanitary facilities and absence of essential production and inspection records.

Inspectors also discovered repeated modifications to the system time on the UV-Vis spectrophotometer workstation used for product testing. Moreover, a review of artificial bezoar batch records showed multiple instances where finished product inspection times were recorded before the completion of final production stages, suggesting data manipulation.

Consequently, regulatory authorities ordered immediate actions: sealing all artificial bezoar raw materials, revoking the company's GMP certificates, recalling all sold products, and initiating an investigation into the company's illegal production activities. These directives highlight the serious nature of the non-compliance identified.