# China NMPA Drug Inspection - Hebei Union Pharmaceutical CO., LTD. - Rehmannia

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/hebei-union-pharmaceutical-co-ltd/86e7b4b2-2731-47d5-b0a5-94dfca042f7b/
Source feed: China

> China NMPA drug inspection for Hebei Union Pharmaceutical CO., LTD. published May 10, 2019. Drug: Rehmannia. The National Medical Products Administration (NMPA) released an announcement on May 8, 2019, detailing significant quali

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement Regarding 23 Batches of Drugs That Do Not Meet Regulations (No. 22 of 2019)
- Company Name: Hebei Union Pharmaceutical CO., LTD.
- Publication Date: 2019-05-10
- Drug Name: Rehmannia
- Inspection Finding: Content determination, acid-insoluble ash, total ash
- Action Taken: The relevant companies have been ordered to suspend sales and use, recall the products, investigate the reasons for non-compliance, and thoroughly rectify the issues. The relevant provincial drug regulatory authorities will investigate the aforementioned companies and entities for their illegal production and sale of counterfeit and substandard drugs in accordance with Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China," and will complete the investigation and processing and publish the results within three months of receiving the inspection report.
- Summary: The National Medical Products Administration (NMPA) released an announcement on May 8, 2019, detailing significant quality control issues across 23 batches of drugs from eight different manufacturers. Comprehensive testing by various provincial drug control institutes revealed multiple instances of non-compliance. Noteworthy violations included the detection of "visible foreign matter" in paclitaxel injections produced by companies such as Shanxi Zhendong Taisheng Pharmaceutical Co., Ltd. and Harbin Pharmaceutical Group Biotechnology Co., Ltd. Additionally, Nanjing Baijingyu Pharmaceutical Co., Ltd. faced issues with "particle size" in 16 batches of chlortetracycline hydrochloride eye ointment. Other companies, including Hebei Kangyiqiang Pharmaceutical Co., Ltd. and Xinjiang Bencaotang Pharmaceutical Co., Ltd., were cited for discrepancies in "content determination," "acid-insoluble ash," and "total ash" for Rehmannia glutinosa, while peppermint from Ningxia Northwest Medicinal Materials Technology Co., Ltd. failed on "appearance" standards. The NMPA has mandated that the implicated enterprises immediately suspend sales, recall affected products, thoroughly investigate the root causes of these failures, and implement robust corrective measures. Furthermore, provincial drug regulatory authorities are required to investigate these illegal activities under Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, with findings and resolutions to be publicly disclosed within three months.

Company: https://www.globalkeysolutions.net/companies/hebei-union-pharmaceutical-co-ltd/c2692895-8526-45c4-8536-1f1030df3fac/