# China NMPA Drug Inspection - Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd. - Lightly fermented black soybeans

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/bozhou-haomen-traditional-chinese-medicine-pieces-co-ltd/d7f19084-b50b-4a6a-a79b-9c14c9e8cd9b/
Source feed: China

> China NMPA drug inspection for Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd. published October 25, 2019. Drug: Lightly fermented black soybeans. The National Medical Products Administration (NMPA) of China announced in October 2019, through Announcement No. 75, tha

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 75 of 2019 from the National Medical Products Administration regarding 83 batches of drugs that did not meet the requirements.
- Company Name: Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2019-10-25
- Drug Name: Lightly fermented black soybeans
- Inspection Finding: Properties do not meet regulations
- Action Taken: Drug regulatory authorities have required relevant enterprises and units to take risk control measures such as suspending sales and use, and recalling products, and to investigate the reasons for non-compliance and implement effective rectification. The National Medical Products Administration has required relevant provincial drug regulatory authorities to organize investigations into the illegal activities of the aforementioned enterprises and units in producing and selling counterfeit and substandard drugs in accordance with the "Drug Administration Law of the People's Republic of China," and to complete the investigation and handling of the relevant enterprises or units and make the results public within three months from the date of receiving the inspection report.
- Summary: The National Medical Products Administration (NMPA) of China announced in October 2019, through Announcement No. 75, that 83 batches of drugs from 68 companies failed to meet quality regulations. Notable companies implicated included Bicon Pharmaceutical Xinyi Group, Tianjin Jinyao Group Hubei Tianyao Pharmaceutical, Shaanxi Xingbang Pharmaceutical, and various traditional Chinese medicine (TCM) manufacturers. The violations spanned critical quality attributes. Issues for injectables like Dexamethasone Sodium Phosphate and Sodium Alginate Diester involved "related substances" and "visible foreign matter," indicating purity and contamination concerns. Oral solutions, such as Lactulose, exhibited "microbial limits" failures. Many products, including Piperacillin Sodium/Tazobactam Sodium for Injection, Synovitis Tablets, Tianma Zhuifeng Ointment, Psoralea corylifolia, and Saposhnikovia divaricata, failed "content determination" tests, suggesting incorrect active ingredient levels. Furthermore, TCM products like Niuhuang Jiedu Tablets contained "other plant tissues," while several fermented soybean batches showed "properties" (appearance) deviations. Operating under the "Drug Administration Law of the People's Republic of China" and relevant pharmacopoeial standards, the NMPA mandated immediate actions. Companies must cease sales, recall affected drugs, investigate the root causes of non-compliance, and implement corrective measures. Provincial drug regulatory authorities are required to investigate these illegal activities and publicly report their findings within three months, reinforcing the NMPA's commitment to drug quality and patient safety.

Company: https://www.globalkeysolutions.net/companies/bozhou-haomen-traditional-chinese-medicine-pieces-co-ltd/df9113d5-2c12-4f64-ab68-0c9827cdd2b3/