# China NMPA Drug Inspection - Ningbo Liwah Pharmaceutical Co. Ltd. - Ginkgo leaves

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/ningbo-liwah-pharmaceutical-co-ltd/9cd39f4c-14e0-4756-b513-6dc52bf87726/
Source feed: China

> China NMPA drug inspection for Ningbo Liwah 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: Ningbo Liwah Pharmaceutical Co. Ltd.
- Publication Date: 2015-07-02
- Drug Name: Ginkgo leaves
- Inspection Finding: The product failed the random inspection, but the company's self-inspection results were satisfactory. The self-inspection sample was a company-retained sample, indicating that the quality of the company-retained sample is inconsistent with that of the commercially available product.
- Action Taken: Immediately recall the substandard batches of medicines; for batches that passed self-inspection, re-inspection must be conducted based on the actual products sold on the market, and the results must be reported; relevant departments should conduct a thorough investigation into the discrepancies between the product samples retained and the products sold on the market.
- 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/ningbo-liwah-pharmaceutical-co-ltd/201269ca-bc2a-47db-9846-16145f4a4a78/