# China NMPA Drug Inspection - Tonghua ZhongSheng Pharmaceutical Co., Ltd. - Longze Bear Bile Capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/tonghua-zhongsheng-pharmaceutical-co-ltd/f6c30951-9630-41a1-b171-90eb7cf17606/
Source feed: China

> China NMPA drug inspection for Tonghua ZhongSheng Pharmaceutical Co., Ltd. published July 14, 2022. Drug: Longze Bear Bile Capsules. On July 14, 2022, the National Medical Products Administration (NMPA) issued Announcement No. 32 of 2022, identifying 19

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 32 of 2022 from the National Medical Products Administration regarding 19 batches of drugs that did not meet the requirements.
- Company Name: Tonghua ZhongSheng Pharmaceutical Co., Ltd.
- Publication Date: 2022-07-14
- Drug Name: Longze Bear Bile Capsules
- Inspection Finding: The properties and disintegration time did not meet the requirements.
- Action Taken: Risk control measures such as suspending sales and use, and recalling products; investigating and rectifying the reasons for non-compliance; and initiating an investigation.
- Summary: On July 14, 2022, the National Medical Products Administration (NMPA) issued Announcement No. 32 of 2022, identifying 19 batches of drugs that failed to meet national quality standards. The non-compliant products were produced by 16 companies, notably including Ruiyang Pharmaceutical Co., Ltd., Shanghai Diran Dancheng Pharmaceutical Co., Ltd., Tonghua Zhongsheng Pharmaceutical Co., Ltd., and several traditional Chinese medicine producers such as Jiangsu Donglian Pharmaceutical Co., Ltd. and Tibet Changdu Tibetan Medicine Factory.

Testing conducted by various provincial institutes revealed several significant violations. Major safety and quality issues included the presence of hydrogen sulfide in injections, prohibited pesticide residues in herbal products, and failure to meet microbial limits. Other failures involved incorrect chemical content levels, poor disintegration times, and inconsistencies in weight uniformity and appearance. These violations represent a failure to adhere to the Drug Administration Law of the People's Republic of China and the standards set by the Chinese Pharmacopoeia (2015 and 2020 editions).

In response, the NMPA has ordered immediate risk control measures, requiring the involved companies to suspend sales, stop use, and initiate product recalls. Manufacturers must investigate the root causes of these failures and implement corrective actions. Furthermore, provincial authorities have been directed to organize formal investigations into suspected illegal activities and publicly disclose the findings to ensure consumer safety and industrial compliance.

Company: https://www.globalkeysolutions.net/companies/tonghua-zhongsheng-pharmaceutical-co-ltd/9da210dd-d8a4-449d-8cd9-7667bffa52cb/