# China NMPA Drug Inspection - SHANDONG LUYE PHARMACEUTICAL CO., LTD - Ganoderma lucidum capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shandong-luye-pharmaceutical-co-ltd/5d9aa1a2-5d61-4be5-bf7a-5a89678f1dd0/
Source feed: China

> China NMPA drug inspection for SHANDONG LUYE PHARMACEUTICAL CO., LTD published August 17, 2018. Drug: Ganoderma lucidum capsules. The National Medical Products Administration (NMPA) issued Announcement No. 73 of 2018 on August 17, 2018, detailing non

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 73 of 2018 from the National Medical Products Administration regarding 12 batches of drugs that did not meet the requirements.
- Company Name: SHANDONG LUYE PHARMACEUTICAL CO., LTD
- Publication Date: 2018-08-17
- Drug Name: Ganoderma lucidum capsules
- Inspection Finding: [Check] (Moisture content), (Quantity variation)
- Action Taken: Relevant drug regulatory authorities have taken control measures such as sealing and seizing, requiring enterprises to suspend sales and use, recall products, and rectify the situation. The National Medical Products Administration has instructed relevant provincial drug regulatory authorities to investigate the aforementioned enterprises and units for illegal activities such as producing and selling counterfeit and substandard drugs in accordance with Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China," and to complete the investigation and handling of the relevant enterprises or units within three months from the date of receiving the inspection report and to publicly disclose the results.
- Summary: The National Medical Products Administration (NMPA) issued Announcement No. 73 of 2018 on August 17, 2018, detailing non-compliance across 12 batches of drugs from 11 companies. Inspections conducted by provincial drug testing institutions identified significant quality control deficiencies. Key violations included: Peppermint (six batches from companies like Bozhou Boyaotang Pharmaceutical Co., Ltd.) had issues with appearance, microscopic characteristics, and thin-layer chromatography. Angelica pubescens (three batches, e.g., from Chengdu Hexiangtian Pharmaceutical Co., Ltd.) failed on appearance, thin-layer chromatography, and content determination. Ganoderma lucidum capsules from Shandong Luyao Pharmaceutical Co., Ltd. were substandard in moisture content and fill weight variation. Folic acid tablets from Yantai Zhongzhou Pharmaceutical Co., Ltd. showed non-compliance with related substances and dissolution rate. These deficiencies fall under the regulatory framework of the *Drug Administration Law of the People's Republic of China* and relevant Pharmacopoeia standards. In response, regulatory authorities initiated immediate control measures, including product sealing, seizure, suspension of sales, recalls, and required rectification. Provincial drug authorities are mandated to investigate these companies for illegal activities related to producing and selling substandard drugs, with findings to be completed and publicly disclosed within three months. This action underscores NMPA's commitment to ensuring drug quality and patient safety.

Company: https://www.globalkeysolutions.net/companies/shandong-luye-pharmaceutical-co-ltd/84cebb4b-fc50-4fcc-8409-88461864f468/