# China NMPA Drug Inspection - Tonghua ZhongSheng Pharmaceutical Co., Ltd. - Yanlixiao Capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/tonghua-zhongsheng-pharmaceutical-co-ltd/ab4c91e2-ad8d-4a20-8ef4-2a015741a457/
Source feed: China

> China NMPA drug inspection for Tonghua ZhongSheng Pharmaceutical Co., Ltd. published June 29, 2018. Drug: Yanlixiao Capsules. The National Medical Products Administration (NMPA) issued an announcement on June 28, 2018, detailing non-compliance is

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 50 of 2018 from the National Medical Products Administration regarding 13 batches of drugs that did not meet the requirements.
- Company Name: Tonghua ZhongSheng Pharmaceutical Co., Ltd.
- Publication Date: 2018-06-29
- Drug Name: Yanlixiao Capsules
- Inspection Finding: The difference in filling volume does not meet the requirements.
- Action Taken: The 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; and have initiated investigations into the 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 have set a time limit of 3 months to complete the investigation and handle the case and make the results public.
- Summary: The National Medical Products Administration (NMPA) issued an announcement on June 28, 2018, detailing non-compliance issues found in thirteen batches of drugs manufactured by multiple pharmaceutical companies. Investigations conducted by various provincial drug control institutes revealed significant quality deficiencies in products with batch numbers primarily from 2017.

Key violations included:
- **Disintegration time failure:** Affecting Compound Gentian Sodium Bicarbonate Tablets from Jilin Luwang Pharmaceutical Co., Ltd., indicating potential issues with drug release and efficacy.
- **Appearance and Extractives non-compliance:** Observed in Chicken Gizzard Lining from companies including Hebei Quantai Pharmaceutical Co., Ltd. and Shandong Shengyin Duobao Traditional Chinese Medicine Pieces Technology Co., Ltd., suggesting poor raw material quality or processing affecting drug characteristics.
- **Microbial limits breach:** Found in Xiaoshuan Enteric-coated Capsules from Sanmenxia Sainov Pharmaceutical Co., Ltd., posing a risk to patient safety due to contamination.
- **Fill weight variation:** In Yanlixiao Capsules by Tonghua Yisheng Pharmaceutical Co., Ltd., leading to inconsistent dosing.
- **Related substances exceeding limits:** Identified in Folic Acid Tablets from Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd., impacting drug purity and safety.
- **Excessive sulfur dioxide residue:** Detected in Angelica dahurica from Hubei Kangjin Pharmaceutical Co., Ltd., a common issue in Chinese medicinal materials affecting quality and potentially human health.

Operating under the *Drug Administration Law of the People's Republic of China*, the NMPA mandated immediate control measures, including product seizures, sales suspension, recalls, and required rectifications. Provincial authorities are instructed to investigate these companies for illegal activities related to substandard drug production and publicize findings within three months. This action underscores the NMPA's commitment to upholding drug quality and safety standards.

Company: https://www.globalkeysolutions.net/companies/tonghua-zhongsheng-pharmaceutical-co-ltd/b8e33c06-96ca-4044-9019-baf2430e3359/