# China NMPA Drug Inspection - Shenzhen Neptunus Pharmaceutical Co., Ltd. - Ginkgo leaves

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shenzhen-neptunus-pharmaceutical-co-ltd/a44d9204-a293-4045-8ea7-64eb5623851a/
Source feed: China

> China NMPA drug inspection for Shenzhen Neptunus Pharmaceutical Co., Ltd. published July 02, 2015. Drug: Ginkgo leaves. From June 16 to 25, 2015, China's State Food and Drug Administration (SFDA) conducted a special supervision and sampling

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 25 of 2015 from the State Food and Drug Administration on the Preliminary Results of the Special Supervision and Sampling Inspection of Ginkgo Leaf Drugs
- Company Name: Shenzhen Neptunus Pharmaceutical Co., Ltd.
- Publication Date: 2015-07-02
- Drug Name: Ginkgo leaves
- Inspection Finding: The product failed the random inspection, and the company's self-inspection also showed that it was substandard, but the company failed to complete the recall as required, and the product is still being sold on the market. This indicates that the company's self-inspection was not thorough and the recall was incomplete.
- Action Taken: The authorities are ordered to recall all substandard products sold on the market by July 10; relevant provincial bureaus are to strengthen supervision to ensure that no substandard products are found in random inspections after the recall deadline.
- Summary: From June 16 to 25, 2015, China's State Food and Drug Administration (SFDA) conducted a special supervision and sampling inspection of Ginkgo Leaf drugs, leading to significant findings under its regulatory framework. Out of 284 batches tested, 67 (23.6%) were found substandard, involving 24 pharmaceutical manufacturers.
A key issue identified was discrepancies in self-inspection. Four companiesHeilongjiang Tianhong Pharmaceutical, Jilin Kuahai Biochemical, Ningbo Lihua Pharmaceutical, and Hunan Huana Pharmaceuticalhad products that passed their internal quality checks but failed the SFDA's market surveillance. This indicated inconsistencies between their retained samples and the products sold to consumers. These companies were required to immediately recall the affected batches and re-inspect all previously cleared products from the market, with results due by July 10th.
Furthermore, thirteen companies, including Guilin Xingda Pharmaceutical and Shenzhen Haiwang Pharmaceutical, were cited for incomplete recalls of previously identified substandard Ginkgo Leaf drugs, despite earlier SFDA announcements and deadlines. Their continued presence on the market highlighted inadequate self-inspection and recall processes. The SFDA mandated these companies to complete comprehensive recalls of all substandard products by July 10th, with provincial authorities instructed to intensify supervision.
The SFDA also ordered in-depth investigations into the four companies with self-inspection discrepancies, focusing on potential evidence alteration or evasion. While most manufacturers' self-reports were deemed reliable and market cleanup efforts showed results, these inspections underscored the need for rigorous quality control and full compliance with recall directives.

Company: https://www.globalkeysolutions.net/companies/shenzhen-neptunus-pharmaceutical-co-ltd/c14c52c0-9330-45d0-9204-06d2c86e9cd3/