# China NMPA Drug Inspection - Henan Kanghua Pharmaceutical Co., Ltd. - Sanhuang tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/henan-kanghua-pharmaceutical-co-ltd/f22290c1-202a-41dd-abac-cc755dbaab01/
Source feed: China

> China NMPA drug inspection for Henan Kanghua Pharmaceutical Co., Ltd. published September 13, 2018. Drug: Sanhuang tablets. On September 13, 2018, the Henan Provincial Food and Drug Administration reported findings from drug inspections reveali

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from the Henan Provincial Food and Drug Administration regarding four batches of substandard drugs (No. 10, 2018)
- Company Name: Henan Kanghua Pharmaceutical Co., Ltd.
- Publication Date: 2018-09-13
- Drug Name: Sanhuang tablets
- Inspection Finding: Properties
- Action Taken: Necessary risk control measures such as sealing up, seizing, and suspending sales will be implemented, and the units responsible for the source of the inspected goods will be investigated and dealt with in accordance with the law.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/henan-kanghua-pharmaceutical-co-ltd/65fe6acd-7740-40b0-854c-ef43a01a3d24/