# China NMPA Drug Inspection - Bozhou Hongda Traditional Chinese Medicine Pieces Technology Co., Ltd. - Mountain Pseudobulbus Cremastrae

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/bozhou-hongda-traditional-chinese-medicine-pieces-technology-co-ltd/c4f8b455-9042-4e4e-9e2a-e952c893b4ef/
Source feed: China

> China NMPA drug inspection for Bozhou Hongda Traditional Chinese Medicine Pieces Technology Co., Ltd. published October 31, 2019. Drug: Mountain Pseudobulbus Cremastrae. The Hubei Province Drug Quality Announcement, published on October 31, 2019, details the findings from drug quality samp

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Hubei Province Drug Quality Bulletin (Issue 3, 2018)
- Company Name: Bozhou Hongda Traditional Chinese Medicine Pieces Technology Co., Ltd.
- Publication Date: 2019-10-31
- Drug Name: Mountain Pseudobulbus Cremastrae
- Inspection Finding: Properties
- Action Taken: The food and drug administration departments of each city (prefecture) shall investigate and handle such cases in accordance with the provisions of the "Drug Administration Law of the People's Republic of China," and promptly report the results and relevant information to the provincial bureau. For drugs verified to be produced by non-labeled manufacturers or without a clear purchase channel, the source of the problematic drugs shall be traced to the bottom and thoroughly investigated; if a crime is suspected, the case shall be promptly transferred to the public security organs for criminal prosecution.
- Summary: The Hubei Province Drug Quality Announcement, published on October 31, 2019, details the findings from drug quality sampling inspections conducted during the third quarter of 2018. These inspections, carried out by Hubei food and drug administration departments, identified 107 batches of non-compliant drugs from numerous pharmaceutical manufacturers, pharmacies, and healthcare facilities across the province. Key violations encompassed critical quality specification issues, including improper pH values, excessive moisture content, unacceptable impurity levels, inconsistent content uniformity, poor dissolution rates, and exceeding microbial limits. These deficiencies were found in finished pharmaceutical preparations, traditional Chinese medicinal materials, and hospital-prepared medications. A significant finding included several counterfeit drugs, such as Atorvastatin Calcium Tablets, where identified manufacturers explicitly denied their production. Additionally, some samples were found to have been stored at temperatures exceeding specified conditions. The regulatory framework for these actions includes the "Drug Administration Law of the People's Republic of China," the Chinese Pharmacopoeia, and other national and provincial drug standards. Affected entities are required to investigate these issues, implement corrective measures, and report findings to the Provincial Bureau. Suspected criminal activity, particularly involving unverified manufacturers or unclear drug sourcing, mandates prompt referral to public security authorities for prosecution, underscoring the commitment to drug safety.

Company: https://www.globalkeysolutions.net/companies/bozhou-hongda-traditional-chinese-medicine-pieces-technology-co-ltd/5dbed28f-b171-4d63-9764-66d29fc79950/