# China NMPA Drug Inspection - Gansu Provincial Guocao Pharmaceutical Co., Ltd. - Lightly fermented black soybeans

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/gansu-provincial-guocao-pharmaceutical-co-ltd/f82c815a-8040-429e-90dd-ba5274998b20/
Source feed: China

> China NMPA drug inspection for Gansu Provincial Guocao Pharmaceutical Co., Ltd. published November 26, 2019. Drug: Lightly fermented black soybeans. The National Medical Products Administration (NMPA) of China issued Announcement No. 85 of 2019 on November 26, 2019, de

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 85 of 2019 from the National Medical Products Administration regarding 57 batches of drugs that did not meet the requirements.
- Company Name: Gansu Provincial Guocao Pharmaceutical Co., Ltd.
- Publication Date: 2019-11-26
- 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; to investigate the reasons for non-compliance and to make effective rectifications; and to organize investigations by relevant provincial drug regulatory authorities, and to complete the investigation and handling and make the results public within three months.
- Summary: The National Medical Products Administration (NMPA) of China issued Announcement No. 85 of 2019 on November 26, 2019, detailing significant drug quality issues discovered across 57 batches produced by 40 companies. Testing by various drug inspection institutions revealed multiple non-compliant drugs, ranging from chemical preparations to traditional Chinese medicine components. Prominent violations included Kangpu Pharmaceutical Co., Ltd. and Jiangsu Jurong Pharmaceutical Group Co., Ltd. for issues with product appearance. Shanxi Guorun Pharmaceutical Co., Ltd.'s Acetylcysteine Inhalation Solution failed due to hydrogen sulfide and related substances, while Guangxi Wuzhou Sanjian Pharmaceutical Co., Ltd.'s Cold and Cough Syrup had content determination failures. Numerous traditional Chinese medicine companies, including Bozhou Zhongqiang Traditional Chinese Medicine Pieces Co., Ltd. and Xinjiang Bencaotang Pharmaceutical Co., Ltd., faced non-compliance for substances like Psoralea corylifolia, Pinellia ternata, and Dragon's Blood, with issues covering appearance, identification, extractives, moisture content, and in some cases, the detection of unauthorized substances like 808 scarlet and rosin acid. Operating under the "Drug Administration Law of the People's Republic of China" and national pharmacopoeia standards, the NMPA mandated immediate risk control measures, including product sales suspension, usage halt, and recalls. All implicated companies are required to investigate the root causes of non-compliance and implement effective rectification. Provincial drug regulatory authorities were instructed to conduct thorough investigations into these violations within three months, publicize findings, and ensure inter-agency cooperation in tracing and resolving these critical quality deviations.

Company: https://www.globalkeysolutions.net/companies/gansu-provincial-guocao-pharmaceutical-co-ltd/8fcc1285-0de9-4507-bb58-e190405f1f2b/