China NMPA Drug Inspection - Bozhou Xinghe Pharmaceutical Co., Ltd. - Bletilla striata

On December 14, 2017, Fujian Province's drug regulatory departments, under the National Medical Products Administration (NMPA), announced findings from drug quality supervision and sampling inspections. The inspections, conducted across drug production, distribution, and user units in the province, aimed to enhance drug quality oversight and ensure public medication safety. A total of 96 batches of drugs, primarily Traditional Chinese Medicine (TCM) pieces, were found non-compliant with quality standards.

Key violations included non-adherence to appearance, properties, and identification requirements (such as microscopic characteristics and thin-layer chromatography). Other significant issues encompassed excessive moisture content, presence of heavy metals and harmful elements, sulfur dioxide residue, inaccurate total ash, presence of related substances, and discrepancies in weight or content. Certain products were also found to be adulterated with unapproved dyes, including Acid Red 73 and Tartrazine.

The regulatory framework underpinning these inspections primarily involved the "Drug Administration Law of the People's Republic of China" and various editions of the "Chinese Pharmacopoeia." As a result, regulatory authorities are mandated to conduct thorough investigations and implement legal actions against all implicated drugs and entities. A specific requirement involves investigating the source and handling disclaimed products where manufacturers deny production.