# China NMPA Drug Inspection - Henan Baiyuankang Pharmaceutical Co., Ltd. - Cardamom

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/henan-baiyuankang-pharmaceutical-co-ltd/41777f03-c1ee-4378-b503-c499511c0d23/
Source feed: China

> China NMPA drug inspection for Henan Baiyuankang Pharmaceutical Co., Ltd. published January 18, 2019. Drug: Cardamom. This announcement from the Henan Provincial Drug Administration, published on January 18, 2019, details findings from in

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Henan Provincial Drug Administration Regarding 5 Batches of Substandard Drugs (Issue 1, 2019)
- Company Name: Henan Baiyuankang Pharmaceutical Co., Ltd.
- Publication Date: 2019-01-18
- Drug Name: Cardamom
- Inspection Finding: Impurities are not up to standard
- Action Taken: The Henan Provincial Drug Administration has instructed relevant food and drug regulatory departments to take necessary risk control measures such as sealing, seizing, and suspending the sale of substandard drugs, and to investigate and punish the units that sourced the samples in accordance with the law.
- Summary: This announcement from the Henan Provincial Drug Administration, published on January 18, 2019, details findings from inspections revealing five batches of substandard drugs from four manufacturers. The inspections, conducted by various municipal and county drug inspection institutes, identified significant quality control issues.

Yunnan Longrun Pharmaceutical Co., Ltd. was cited for Weikangling Capsules containing Auramine O, a prohibited substance. Hubei Tongren Hengkang Traditional Chinese Medicine Pieces Co., Ltd.'s Cistanche deserticola failed standards for appearance, moisture, and total ash. Minxian Guiqitang Pharmaceutical Co., Ltd.'s Angelica sinensis and Henan Baiyuankang Pharmaceutical Co., Ltd.'s Angelica dahurica both exhibited unsatisfactory appearance, including insect infestation. Additionally, Henan Baiyuankang Pharmaceutical Co., Ltd.'s Amomum villosum contained unacceptable impurities.

The regulatory framework underpinning these inspections is primarily the Chinese Pharmacopoeia 2015 Edition, alongside specific supplementary test methods for certain items. In response to these violations, the Henan Provincial Drug Administration mandated immediate risk control measures. These include sealing and seizing the affected products, suspending their sale, and initiating legal investigations and penalties against the implicated manufacturing companies to ensure public health and drug quality.

Company: https://www.globalkeysolutions.net/companies/henan-baiyuankang-pharmaceutical-co-ltd/c2473270-07e8-4abb-ad5c-4474e0f0c45c/