# China NMPA Drug Inspection - Guoyao Lerentang Hebei Pharmaceutical Co., Ltd. - ground beetle

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/guoyao-lerentang-hebei-pharmaceutical-co-ltd/e8acf149-58c7-429f-a539-e87292f0dcc2/
Source feed: China

> China NMPA drug inspection for Guoyao Lerentang Hebei Pharmaceutical Co., Ltd. published May 18, 2017. Drug: ground beetle. The State Administration for Market Regulation issued Announcement No. 78 on May 18, 2017, detailing findings from drug 

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 78 of 2017 from the State Administration of Traditional Chinese Medicine regarding 71 batches of substandard prepared slices of traditional Chinese medicine.
- Company Name: Guoyao Lerentang Hebei Pharmaceutical Co., Ltd.
- Publication Date: 2017-05-18
- Drug Name: ground beetle
- Inspection Finding: Forty batches of ground beetles failed to meet standards. The non-compliant items included appearance, extractives, total ash, acid-insoluble ash, moisture, and sulfur dioxide residue.
- Action Taken: The relevant food and drug administration authorities have taken control measures such as sealing and seizing goods, requiring the company to suspend sales and use, recall products, and rectify the situation. Meanwhile, the local food and drug administration authorities where the production company is located will investigate the illegal activities in accordance with the "Drug Administration Law" and publicly disclose the results within a specified timeframe.
- Summary: The State Administration for Market Regulation issued Announcement No. 78 on May 18, 2017, detailing findings from drug testing institutions that revealed 71 batches of unqualified Traditional Chinese Medicine (TCM) decoction pieces produced by 62 companies. Investigations identified significant issues, including 40 batches of substandard Eupolyphaga sinensis and 30 batches of substandard borneol, which failed quality parameters such as appearance, content determination, camphor levels, and non-volatile matter. Additionally, one batch of dodder seed from Guangzhou Zhixin Traditional Chinese Medicine Pieces Co., Ltd. was found to have non-compliant content determination.

In response, provincial food and drug administrations were directed to implement immediate control measures, including sealing, seizing, suspending sales, recalling products, and requiring rectification from the implicated enterprises. Operating under the Drug Administration Law of the People's Republic of China, these administrations are mandated to thoroughly investigate the illegal acts of producing and selling non-compliant drugs. They must publicly disclose the results of their investigations and handling of these enterprises within three months, with severe penalties to be imposed on manufacturers confirmed to be responsible for the substandard products. A clear process for handling enterprise objections regarding product authenticity was also established.

Company: https://www.globalkeysolutions.net/companies/guoyao-lerentang-hebei-pharmaceutical-co-ltd/1260a905-4b06-43fa-a441-3328f0bfdd78/