# China NMPA Drug Inspection - Jinan Hebao Chinese Herbal Medicine Co., Ltd. - Bletilla striata

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jinan-hebao-chinese-herbal-medicine-co-ltd/4919913b-3bbc-4d82-8704-70d695d7b6ad/
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> China NMPA drug inspection for Jinan Hebao Chinese Herbal Medicine Co., Ltd. published July 25, 2017. Drug: Bletilla striata. The Shandong Provincial Food and Drug Administration announced on July 25, 2017, findings from quality sampling inspecti

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Shandong Provincial Food and Drug Administration Regarding 14 Batches of Substandard Drugs (Issue No. 5, 2017)
- Company Name: Jinan Hebao Chinese Herbal Medicine Co., Ltd.
- Publication Date: 2017-07-25
- Drug Name: Bletilla striata
- Inspection Finding: Check - Sulfur dioxide residue
- Action Taken: Control measures such as sealing, seizure, suspension of sales, and product recall were implemented, and the production enterprise and the sampled unit were investigated and dealt with in accordance with relevant laws and regulations.
- Summary: The Shandong Provincial Food and Drug Administration announced on July 25, 2017, findings from quality sampling inspections that identified 14 batches of substandard drugs. The regulatory action involved multiple pharmaceutical companies and Traditional Chinese Medicine (TCM) decoction piece manufacturers.

Shijiazhuang Northern Pharmaceutical Co., Ltd. was cited for one batch of Antiviral Oral liquid (batch 161117) that failed an inspection item related to its characteristic spectrum. Additionally, thirteen batches of various TCM decoction pieces from twelve different manufacturers were found to be substandard. These manufacturers include Anguo Tongkang Pharmaceutical Co., Ltd., Bozhou Huayun Traditional Chinese Medicine Pieces Co., Ltd., Anhui Guangyintang Traditional Chinese Medicine Co., Ltd., Jinan Hebao Chinese Herbal Medicine Co., Ltd., Anhui Yaozhiyuan Chinese Herbal Medicine Co., Ltd., Anhui Yiyuan Pharmaceutical Co., Ltd., Bozhou Hongda Traditional Chinese Medicine Pieces Technology Co., Ltd., Bozhou Baishi Traditional Chinese Medicine Pieces Co., Ltd., Jiuquan Peifeng Traditional Chinese Medicine Ecological Planting and Processing Co., Ltd., and Shandong Shangdu Pharmaceutical Co., Ltd.

The violations for TCM pieces were diverse, encompassing failures in content determination, characteristic properties, identification, moisture content, sulfur dioxide residue, total ash, and specific active ingredient levels. These were measured against the standards set by the Chinese Pharmacopoeia (2010 and 2015 Editions) and relevant State Food and Drug Administration approvals.

As a result, municipal food and drug administrations initiated immediate control measures, including sealing, seizing, suspending sales, and recalling the affected products. Manufacturers and sampled units are subject to investigation and regulatory enforcement. Furthermore, enterprises are mandated to investigate the root causes of these quality deviations, implement corrective and preventive actions, and mitigate future risks, with ongoing supervision from regulatory bodies.

Company: https://www.globalkeysolutions.net/companies/jinan-hebao-chinese-herbal-medicine-co-ltd/2573a032-25de-44a8-a725-d8346c9c0f19/