# China NMPA Inspection - Jilin Jichun Pharmaceutical Co., Ltd. - December 28, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/jilin-jichun-pharmaceutical-co-ltd/1b89c19a-0672-4c03-8803-55cc0456a99b/
Source feed: China

> China NMPA unannounced inspection for Jilin Jichun Pharmaceutical Co., Ltd. published December 28, 2015. An unannounced inspection of Jilin Jichun Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and Jilin Provincial Food a

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Jilin Jichun Pharmaceutical Co., Ltd.
- Company Name: Jilin Jichun Pharmaceutical Co., Ltd.
- Publication Date: 2015-12-28
- Product Type: Drugs
- Summary: An unannounced inspection of Jilin Jichun Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and Jilin Provincial Food and Drug Administration from September 24-26, 2015. The inspection revealed several critical violations of drug manufacturing regulations.

Key findings included the unauthorized addition of raw medicinal powder, specifically plant tissues, to two batches (140801 and 150701) of refined coronary heart disease tablets. This was confirmed through microscopic examination of retained quality control samples, indicating a serious compromise of product integrity and adherence to approved formulations.

Additionally, the company lacked essential standardized operating procedures and internal quality control standards for the recovery and distillation of ethanol used in the reflux extraction of medicinal herbs. Furthermore, significant discrepancies were found between the company's batch production records and its established process specifications regarding ethanol usage. While the process specifications mandated an 8-fold amount of ethanol relative to medicinal herbs, production records indicated an actual 10-fold usage, highlighting inconsistencies in manufacturing processes and record-keeping.

These actions were deemed a severe violation of the *Drug Administration Law* and Good Manufacturing Practice (GMP) regulations. Consequently, the State Food and Drug Administration directed the Jilin Provincial Food and Drug Administration to take stringent measures. These include the immediate revocation of Jilin Jichun Pharmaceutical Co., Ltd.'s GMP certificate, ordering a complete cessation of production, recalling all affected products, and initiating legal investigation and prosecution for the identified violations.

Company: https://www.globalkeysolutions.net/companies/jilin-jichun-pharmaceutical-co-ltd/84771b47-8aa9-48ed-aab2-fd7f24e016f0/