China NMPA Inspection - Anguo City Qiao Traditional Chinese Medicine Pieces Co., Ltd. - January 06, 2017

An unannounced inspection of Anguo Qiao Traditional Chinese Medicine Pieces Co., Ltd. was conducted by the State Food and Drug Administration on December 9-10, 2016, following a complaint. The inspection revealed severe violations of Good Manufacturing Practice (GMP) for Pharmaceuticals. Key findings included strong suspicion that the company was purchasing and reselling traditional Chinese medicine pieces under its own brand. This was substantiated by significant discrepancies where sales volumes for multiple calcined medicinal slices far exceeded recorded raw material, production, and inventory quantities. Further critical issues involved major lapses in documentation integrity. An employee was observed retrospectively completing records, and blank "Finished Product Release Forms" were found pre-signed and stamped by the quality authorized person, alongside other pre-approved blank production documents. Extensive data reliability problems were also identified. High-Performance Liquid Chromatography (HPLC) chromatograms showed injection times occurring after printing times. Finished product inspection samples were taken prematurely, before packaging completion. Essential titrants used for quality control lacked preparation records, and equipment operation logs for the calcining furnace were inconsistent with actual production records, including incorrect batch numbers, missing entries, and time discrepancies. As a result of these findings, particularly concerning data authenticity and the failure of key personnel to fulfill their responsibilities, the Hebei Provincial Food and Drug Administration was directed to revoke the company's GMP certificate and initiate an investigation into the associated illegal activities.