# China NMPA Inspection - Guilin Pharmaceutical Co., Ltd. - May 20, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/guilin-pharmaceutical-co-ltd/8488ee0d-cc5e-422a-b76a-40fc6fcf4b86/
Source feed: China

> China NMPA unannounced inspection for Guilin Pharmaceutical Co., Ltd. published May 20, 2015. An unannounced inspection conducted by the State Food and Drug Administration (SFDA) and the Guangxi Zhuang Autonomous Region Food and Drug Administra

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Guilin Xingda Pharmaceutical Co., Ltd.
- Company Name: Guilin Pharmaceutical Co., Ltd.
- Publication Date: 2015-05-20
- Product Type: drugs
- Summary: An unannounced inspection conducted by the State Food and Drug Administration (SFDA) and the Guangxi Zhuang Autonomous Region Food and Drug Administration from May 9th to 11th, 2015, revealed significant non-compliance issues at Guilin Xingda Pharmaceutical Co., Ltd. The inspection uncovered that the company had unilaterally altered the extraction process for ginkgo leaf extract, switching from a dilute alcohol method to a 3% hydrochloric acid extraction without authorization. Furthermore, Guilin Xingda Pharmaceutical Co., Ltd. was found to have illegally procured ginkgo leaf extract from unqualified suppliers, with this purchased extract also utilizing the unauthorized 3% hydrochloric acid extraction method. These illicitly obtained materials were subsequently used in the production and sale of ginkgo leaf tablets. The company also engaged in the relabeling of purchased ginkgo leaf extract for resale to other pharmaceutical manufacturers and falsified critical batch production and material management records. These actions represent serious violations of the *Drug Administration Law* and applicable Good Manufacturing Practices (GMP) regulations. As a consequence, the company's GMP certificate has been revoked. Guilin Xingda Pharmaceutical Co., Ltd. has been ordered to immediately cease the production, sale, and use of all Ginkgo biloba tablets and to recall affected products. Investigations and prosecutions are underway, with cases potentially involving criminal activity being referred to public security authorities for further action.

Company: https://www.globalkeysolutions.net/companies/guilin-pharmaceutical-co-ltd/8a53776f-b81a-417d-b1c5-ea1cd2d0b0a8/