# China NMPA Drug Inspection - Shaanxi Xingshengde Pharmaceutical Co., Ltd. - betel nut

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shaanxi-xingshengde-pharmaceutical-co-ltd/00c161e5-b449-4a76-b93d-d63b1ecd4e28/
Source feed: China

> China NMPA drug inspection for Shaanxi Xingshengde Pharmaceutical Co., Ltd. published November 02, 2018. Drug: betel nut. The National Medical Products Administration (NMPA) of China announced on November 2, 2018, findings from inspections id

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 110 of 2018 from the National Medical Products Administration regarding 47 batches of drugs that did not meet the requirements.
- Company Name: Shaanxi Xingshengde Pharmaceutical Co., Ltd.
- Publication Date: 2018-11-02
- Drug Name: betel nut
- Inspection Finding: Moisture, aflatoxin
- Action Taken: Relevant drug regulatory authorities have taken control measures such as sealing and seizing, requiring enterprises to suspend sales and use, recall products, and rectify the situation. The National Medical Products Administration has required relevant provincial drug regulatory authorities to investigate the illegal acts of producing and selling counterfeit and substandard drugs by the aforementioned enterprises and units in accordance with Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China, and to complete the investigation and handling of the relevant enterprises or units within three months from the date of receiving the inspection report and to make the results public.
- Summary: The National Medical Products Administration (NMPA) of China announced on November 2, 2018, findings from inspections identifying 47 batches of drugs from 23 enterprises that failed to meet regulatory standards. Major issues included: 24 batches of Doxepin Hydrochloride Tablets from Taicang Pharmaceutical Factory failed for weight variation; 11 batches of areca nuts from ten companies, including Hebei Liankang Pharmaceutical Co., Ltd. and Harbin Pharmaceutical Group Shiyitang, showed non-compliant moisture content and aflatoxin levels; 10 batches of chicken gizzard lining products from ten manufacturers, such as Anguo Juyitang Pharmaceutical Co., Ltd. and Shanxi Guotai Traditional Chinese Medicine Pieces Co., Ltd., failed on extractives; Anhui Tongtai Pharmaceutical Co., Ltd.'s Ganoderma lucidum capsules exceeded microbial limits; and Shanxi Wanhui Pharmaceutical Co., Ltd.'s Qingwei Huanglian Pills exhibited issues with identification (thin-layer chromatography, microscopic identification) and fill weight uniformity. These violations were assessed against the Pharmacopoeia of the People's Republic of China (2015 Edition) and relevant Ministry of Health drug standards. In response, regulatory authorities implemented immediate control measures, including sealing, seizing, suspending sales, product recalls, and mandating rectification. Provincial drug regulatory bodies are required, under Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China, to investigate these enterprises for producing and selling non-compliant drugs. Investigations must conclude within three months, with results made public, underscoring the NMPA's commitment to drug quality and safety.

Company: https://www.globalkeysolutions.net/companies/shaanxi-xingshengde-pharmaceutical-co-ltd/d721aded-17fc-40c3-b6a8-22da4187c0b1/