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

Source: https://www.globalkeysolutions.net/records/china_inspection/jilin-huinan-tianyu-pharmaceutical-co-ltd/e50262a5-1b84-48e1-b103-ecc345268422/
Source feed: China

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

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Jilin Huinan Tianyu Pharmaceutical Co., Ltd.
- Company Name: Jilin Huinan Tianyu Pharmaceutical Co., Ltd.
- Publication Date: 2015-12-28
- Product Type: Drugs
- Summary: An unannounced inspection of Jilin Huinan Tianyu Pharmaceutical Co., Ltd. by the State Food and Drug Administration and Jilin Provincial Food and Drug Administration occurred from September 24-26, 2015. The inspection uncovered serious violations of the "Drug Administration Law" and Good Manufacturing Practice (GMP) regulations.

Key findings included significant product quality and control issues. Microscopic identification of two batches of refined coronary heart disease tablets revealed the presence of unidentifiable plant tissue. Furthermore, discrepancies were found between the company's recorded inventory of Chinese herbal medicines and the actual stock on hand, with some materials completely missing and others showing significant variances. Production process control was also compromised; records indicated substantially less ethanol usage for several batches of refined coronary heart disease tablets than required by the approved manufacturing process. Additionally, the company failed to conduct full-item quality testing on a batch of purchased ethanol, omitting crucial tests. The supplier of this ethanol was unaudited, and the stability of a critical reference solution used in content determination was not properly assessed.

As a result of these serious findings, the State Food and Drug Administration mandated the Jilin Provincial Food and Drug Administration to revoke the company's GMP certificate, order an immediate cessation of production, initiate a recall of all affected products, and pursue legal investigation and punishment for the identified violations. These actions underscore a critical failure in maintaining product quality, inventory control, and adherence to established manufacturing standards.

Company: https://www.globalkeysolutions.net/companies/jilin-huinan-tianyu-pharmaceutical-co-ltd/e406ba27-1dcd-4955-9f5c-ff8c66c15507/