# China NMPA Drug Inspection - Shanghai Dedatang Traditional Chinese Medicine Co., Ltd. - Hawthorn (cleaned hawthorn)

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanghai-dedatang-traditional-chinese-medicine-co-ltd/2b5ee5eb-8fa1-4e12-b551-19437356641f/
Source feed: China

> China NMPA drug inspection for Shanghai Dedatang Traditional Chinese Medicine Co., Ltd. published September 04, 2019. Drug: Hawthorn (cleaned hawthorn). The Shanghai Municipal Drug Administration announced on September 4, 2019, the results of its 2019 drug quality sampling

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Shanghai Municipal Drug Administration's 7th Drug Quality Sampling Inspection Announcement of 2019 (September 4, 2019)
- Company Name: Shanghai Dedatang Traditional Chinese Medicine Co., Ltd.
- Publication Date: 2019-09-04
- Drug Name: Hawthorn (cleaned hawthorn)
- Inspection Finding: Moisture content does not meet regulations
- Action Taken: The Shanghai Municipal Drug Administration has organized relevant regulatory departments to take control measures and investigate and deal with the products in the notice in accordance with the law. It has required the companies or units involved to take control measures such as suspending sales, using or recalling products according to the level of risk, and to find out the reasons and eliminate potential risks.
- Summary: The Shanghai Municipal Drug Administration announced on September 4, 2019, the results of its 2019 drug quality sampling inspections, revealing multiple instances of non-compliance with drug quality and safety standards. These inspections were conducted under the regulatory guidance of the 2015 Chinese Pharmacopoeia and the 2008 Edition Shanghai Processing Regulations, aiming to strengthen quality supervision and ensure market integrity for marketed drugs and pharmaceutical packaging materials.

Six products, primarily traditional Chinese medicinal processed slices, were identified as non-compliant. Issues varied, including deviations in appearance and processing methods for Dried Toad Skin and Salt-processed Eucommia ulmoides, elevated moisture content in Hawthorn, and the presence of non-compliant heavy metals and harmful elements in Licorice. Additionally, Magnolia officinalis failed content determination, and Senna Leaf exhibited unacceptable properties and impurities. Key manufacturers whose products were implicated include Anhui Meiyu Traditional Chinese Medicine Processed Slices Co., Ltd., Shanghai Dedatang Traditional Chinese Medicine Co., Ltd., Anhui Mengshi Traditional Chinese Medicine Slices Co., Ltd., Shanghai Hongqiao Traditional Chinese Medicine Slices Co., Ltd., and Anhui Wansheng Traditional Chinese Medicine Slices Co., Ltd.

As a result, the Shanghai Municipal Drug Administration has mandated that all involved enterprises and units implement immediate control measures. These include suspending sales, usage, or recalling affected products based on their assessed risk level. Furthermore, these entities are required to thoroughly investigate the root causes of the non-compliance and implement corrective actions to eliminate potential risks, with relevant regulatory departments initiating legal proceedings as necessary.

Company: https://www.globalkeysolutions.net/companies/shanghai-dedatang-traditional-chinese-medicine-co-ltd/6d4fd4ca-b898-4c08-ab3c-076ce5371db4/