# China NMPA Drug Inspection - Guangxi Zhongsen Traditional Chinese Medicine Pharmaceutical Co., Ltd. - Bletilla striata

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/guangxi-zhongsen-traditional-chinese-medicine-pharmaceutical-co-ltd/d623e3de-d840-4bf3-b4d4-5a3d074cd629/
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> China NMPA drug inspection for Guangxi Zhongsen Traditional Chinese Medicine Pharmaceutical Co., Ltd. published December 29, 2017. Drug: Bletilla striata. On December 29, 2017, China's State Administration for Market Regulation (NMPA) issued an announcement detailing signifi

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 228 of 2017 from the State Administration of Traditional Chinese Medicine regarding 38 batches of substandard prepared slices of traditional Chinese medicine.
- Company Name: Guangxi Zhongsen Traditional Chinese Medicine Pharmaceutical Co., Ltd.
- Publication Date: 2017-12-29
- Drug Name: Bletilla striata
- Inspection Finding: Characteristics, Identification
- Action Taken: Relevant provincial food and drug administration departments have implemented control measures such as sealing and seizing, requiring enterprises to suspend sales and use, recall products, and carry out rectification. three months, and report relevant information in a timely manner.
- Summary: On December 29, 2017, China's State Administration for Market Regulation (NMPA) issued an announcement detailing significant findings from drug inspections. The regulatory action stemmed from tests conducted by multiple drug testing institutions, including the China National Institutes for Food and Drug Control. The inspections identified 38 batches of traditional Chinese medicine decoction pieces, produced by 29 different enterprises, as substandard.

Key companies implicated include Anhui Yiyuantang Traditional Chinese Medicine Decoction Pieces Technology Co., Ltd., Beijing Bencao Fangyuan Pharmaceutical Co., Ltd., and Anguo Changda Traditional Chinese Medicine Pieces Co., Ltd., among others. The primary violations involved critical quality parameters. For instance, 13 batches of Bletilla striata failed appearance and identification tests, while 23 batches of Amomum villosum were substandard in appearance and content determination, specifically for Bornyl Acetate. Additionally, single batches of Codonopsis pilosula and Eupolyphaga sinensis exhibited appearance deficiencies. These findings violated standards set by the 'Pharmacopoeia of the People's Republic of China' (2015 Edition) and provincial processing specifications.

In response, provincial food and drug administration departments initiated control measures, including product sealing and seizure. The affected enterprises were mandated to cease sales and usage, recall the substandard products, and implement corrective actions. Furthermore, the NMPA directed provincial authorities to investigate these illegal acts in accordance with Articles 73, 74, and 75 of the 'Drug Administration Law of the People's Republic of China,' requiring public disclosure of handling results within three months and timely reporting.

Company: https://www.globalkeysolutions.net/companies/guangxi-zhongsen-traditional-chinese-medicine-pharmaceutical-co-ltd/f675e621-fc08-411c-96a8-ab7b574edc76/