# China NMPA Inspection - Jilin Guoyao Pharmaceutical Co., Ltd. - July 12, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/jilin-guoyao-pharmaceutical-co-ltd/061da851-750c-48c0-99ac-256137b2d028/
Source feed: China

> China NMPA unannounced inspection for Jilin Guoyao Pharmaceutical Co., Ltd. published July 12, 2018. An unannounced inspection of Jilin Guoyao Pharmaceutical Co., Ltd., with findings published on July 11, 2018, revealed significant non-compliance with

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Jilin Guoyao Pharmaceutical Co., Ltd.
- Company Name: Jilin Guoyao Pharmaceutical Co., Ltd.
- Publication Date: 2018-07-12
- Product Type: Drugs
- Summary: An unannounced inspection of Jilin Guoyao Pharmaceutical Co., Ltd., with findings published on July 11, 2018, revealed significant non-compliance with pharmaceutical manufacturing regulations. The inspection, focusing on Baotailing Tablets, identified critical deficiencies across the company’s operations. The primary issues centered on an ineffective quality management system and unreliable data. Violations included the failure to process and quality test raw Chinese medicinal materials according to the Chinese Pharmacopoeia, and a lack of required product quality reviews for batches produced between 2015 and 2017. Furthermore, the company demonstrated inadequate control over changes to processes and equipment, and failed to properly manage deviations, such as the use of expired materials without investigation. Serious data integrity concerns were also noted, with key records being inconsistent, incomplete, or untraceable. Examples include the destruction of material location cards, discrepancies in reported production volumes between batch records and financial documents, and untraceable purchases of critical raw materials like donkey-hide gelatin. The laboratory's instrument usage logs were found to be unreliable and open to modification. Additionally, the company did not conduct on-site audits of its raw material suppliers. These findings indicate that the company's production quality management of Baotailing tablets did not adhere to the Good Manufacturing Practice for Pharmaceuticals (2010 Revision). As a result, the Jilin Provincial Food and Drug Administration was directed to revoke the company's relevant GMP certificates and to pursue legal action regarding the identified illegal and irregular activities.

Company: https://www.globalkeysolutions.net/companies/jilin-guoyao-pharmaceutical-co-ltd/96e11996-46c2-4579-b3f6-50ce498ebf71/