# China NMPA Drug Inspection - Anguo Rendexing Medicinal Herbs Co., Ltd. - yam

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/anguo-rendexing-medicinal-herbs-co-ltd/c0a2f91c-5136-41fe-b10b-88861a2b3491/
Source feed: China

> China NMPA drug inspection for Anguo Rendexing Medicinal Herbs Co., Ltd. published July 13, 2018. Drug: yam. The National Medical Products Administration (NMPA) issued Announcement No. 58 on July 13, 2018, reporting that 42 batch

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 58 of 2018 from the National Medical Products Administration regarding 42 batches of drugs that did not meet the requirements.
- Company Name: Anguo Rendexing Medicinal Herbs Co., Ltd.
- Publication Date: 2018-07-13
- Drug Name: yam
- Inspection Finding: Total ash content, residual sulfur dioxide, leachate, and microscopic characteristics did not meet the requirements.
- 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 instructed relevant provincial drug regulatory authorities to investigate the aforementioned enterprises and units for illegal activities such as producing and selling 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 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 publicly disclose the results.
- Summary: The National Medical Products Administration (NMPA) issued Announcement No. 58 on July 13, 2018, reporting that 42 batches of drugs from 37 companies failed to meet regulatory standards. Various provincial drug testing institutions identified critical quality issues across a range of pharmaceutical products, including traditional Chinese medicines and injectable preparations, from companies like Sichuan Fuqing Pharmaceutical Co., Ltd. and Wuhan Pusheng Pharmaceutical Co., Ltd.

Key violations included substandard content determination, affecting drug efficacy, and issues with total ash, acid-insoluble ash, and extractives in traditional Chinese medicine ingredients such as Rehmannia glutinosa and Chinese yam, indicating impurities or improper processing. Concerns regarding drug purity and safety were raised by failures in "related substances" for Omeprazole Sodium for Injection, suggesting impurities from manufacturing or degradation. Additionally, excessive sulfur dioxide residue in Chinese yam highlighted improper preservation practices, and incorrect fill weight for Lincomycin Lidocaine Gel pointed to manufacturing control issues.

In response, regulatory authorities implemented immediate control measures, including product sealing, seizure, sales suspension, and recalls, requiring companies to rectify the identified problems. Under Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, provincial drug regulatory bodies were mandated to investigate these companies for illegal production and sale of non-compliant drugs. The NMPA required these investigations and their public disclosure within three months, emphasizing the administration's commitment to ensuring drug quality and public safety.

Company: https://www.globalkeysolutions.net/companies/anguo-rendexing-medicinal-herbs-co-ltd/060a9249-1791-4a82-8904-47cb0f374267/