China NMPA Drug Inspection - Henan Kanghua Pharmaceutical Co., Ltd. - Bupleurum Injection

On September 13, 2018, the Henan Provincial Food and Drug Administration reported findings from drug inspections revealing several instances of substandard products. Inspections, conducted by various institutes, identified significant quality control deficiencies across multiple manufacturers. Henan Kanghua Pharmaceutical Co., Ltd. was cited for two products: Bupleurum Injection (batch 16071201A) containing visible foreign matter, and Sanhuang Tablets (batch 16061501) exhibiting a substandard appearance. Shanghai Modern Hasen (Shangqiu) Pharmaceutical Co., Ltd.'s Glycyrrhizic Acid Diammonium Injection (batch 1509140141) also failed due to visible foreign matter. Additionally, Henan Hongbo Pharmaceutical Co., Ltd.'s Poria Cocos Peel (batch 151101) was non-compliant regarding moisture, total ash, and acid-insoluble ash content. These issues violate national drug standards, including various editions of the Chinese Pharmacopoeia and specific National Drug Administration standards, falling under the regulatory framework overseen by the National Medical Products Administration (NMPA). In response, the Henan Provincial Food and Drug Administration mandated immediate risk control measures, including the sealing, seizing, and suspension of sales for the identified substandard drugs. Furthermore, the administration ordered thorough investigations and legal action against the manufacturers and suppliers responsible for these quality failures, emphasizing a commitment to upholding pharmaceutical quality and patient safety.