# China NMPA Inspection - Shaanxi Ziguang Chenji Pharmaceutical Co., Ltd. - March 15, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/shaanxi-ziguang-chenji-pharmaceutical-co-ltd/585b8082-4388-4223-8e0f-8452ce7d6955/
Source feed: China

> China NMPA unannounced inspection for Shaanxi Ziguang Chenji Pharmaceutical Co., Ltd. published March 15, 2017. Shaanxi Ziguang Chenji Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration's Verification Ce

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shaanxi Ziguang Chenji Pharmaceutical Co., Ltd.
- Company Name: Shaanxi Ziguang Chenji Pharmaceutical Co., Ltd.
- Publication Date: 2017-03-15
- Product Type: Drugs
- Summary: Shaanxi Ziguang Chenji Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration's Verification Center and the Baoji Municipal Food and Drug Administration from January 10-12, 2017. The inspection, initiated by sampling, uncovered significant non-compliance with pharmaceutical manufacturing standards. Key issues included the suspected production of Qingre Jiedu tablets in deviation from the Chinese Pharmacopoeia, specifically the undeclared addition of gardenia, which the company acknowledged, leading to a product recall. Material management was found to be disorganized, with missing issuance records for key ingredients, making production activities untraceable. Furthermore, batch production records lacked necessary details, and equipment usage records for the extraction process were absent. The inspection also identified deviations during the production of Guipi pills, such as the use of unpitted jujubes contrary to the prescription and discrepancies in longan pulp inventory. These findings demonstrated a failure to comply with the "Good Manufacturing Practice for Pharmaceuticals" (2010 revision). Consequently, the provincial bureau was instructed to revoke the company's GMP certificate, conduct a comprehensive assessment of product quality and safety risks, implement appropriate risk control measures, and initiate a formal investigation into the identified deficiencies.

Company: https://www.globalkeysolutions.net/companies/shaanxi-ziguang-chenji-pharmaceutical-co-ltd/9c17af94-a4aa-48ca-a286-7bc269b0ac0d/