# China NMPA Inspection - Jilin Changyuan Pharmaceutical Co., Ltd. - September 18, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/jilin-changyuan-pharmaceutical-co-ltd/c51f10a9-aa6e-486a-8cb4-677d502233d1/
Source feed: China

> China NMPA unannounced inspection for Jilin Changyuan Pharmaceutical Co., Ltd. published September 18, 2016. An unannounced inspection of Jilin Changyuan Pharmaceutical Co., Ltd., conducted from June 14-16, 2016, by the State Food and Drug Administration and 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Jilin Changyuan Pharmaceutical Co., Ltd.
- Company Name: Jilin Changyuan Pharmaceutical Co., Ltd.
- Publication Date: 2016-09-18
- Product Type: Drugs
- Summary: An unannounced inspection of Jilin Changyuan Pharmaceutical Co., Ltd., conducted from June 14-16, 2016, by the State Food and Drug Administration and Jilin Provincial Food and Drug Administration, uncovered significant violations. The inspection was prompted by a complaint/report.
The primary issue identified was the unauthorized substitution of raw materials in the production of brain peptide capsules. The company was found to be illegally purchasing and using brain stem residue from Luzhou Ruixing Bioengineering Co., Ltd., and pig brain hydrolysate from Anhui Kebao Bioengineering Co., Ltd., as substitutes for the approved pig brain extract. The purchased brain stem residue, a byproduct of another extraction process, and the hydrolysate, derived from cholesterol extraction, were directly incorporated into the capsules, deviating significantly from the registered manufacturing process.
Furthermore, the investigation revealed deliberate fabrication of critical production documents. The company manipulated material ledgers, batch records, and cold storage location cards to falsely show pig brain purchases and processing, despite financial records indicating no pig brain acquisitions in 2016 and the relevant workshop being non-operational. This systematic falsification aimed to conceal the use of unapproved raw materials and misrepresent production activities.
These actions contravened the "Drug Administration Law of the People's Republic of China" and Good Manufacturing Practice (GMP) regulations. Consequently, regulatory authorities ordered Jilin Changyuan Pharmaceutical Co., Ltd. to seal its brain peptide capsule inventory, recall all sold products, and initiated the revocation of its Drug GMP Certificate. An investigation into the company's illegal production practices is also underway.

Company: https://www.globalkeysolutions.net/companies/jilin-changyuan-pharmaceutical-co-ltd/4362fe8a-9863-4f38-8350-730123352106/