# China NMPA Inspection - Liaoning Yuhuang Pharmaceutical Co., Ltd. - March 16, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/liaoning-yuhuang-pharmaceutical-co-ltd/d3df5ad3-1b68-4b74-8901-92eb0e2bd33a/
Source feed: China

> China NMPA unannounced inspection for Liaoning Yuhuang Pharmaceutical Co., Ltd. published March 16, 2016. An unannounced inspection of Liaoning Yuhuang Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and Liaoning Provincial

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Liaoning Yuhuang Pharmaceutical Co., Ltd.
- Company Name: Liaoning Yuhuang Pharmaceutical Co., Ltd.
- Publication Date: 2016-03-16
- Product Type: Drugs
- Summary: An unannounced inspection of Liaoning Yuhuang Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and Liaoning Provincial Food and Drug Administration from February 25-29, 2016, following a complaint. The inspection uncovered significant violations of pharmaceutical manufacturing standards. Key issues included the deliberate fabrication of batch production records, material ledgers, and false raw material purchase invoices. The company consistently produced an excess yield of hepatocyte growth factor solution, approximately 27,790 grams more than approved between 2014-2015, by manipulating records and blending the surplus into other batches. Furthermore, the audit of their primary raw material supplier, Jiangsu Dongtai Sizhihai Frozen Food Factory, was incomplete. The supplier was found to source piglet livers from unverified third-party companies, compromising raw material quality. Electronic records for critical testing equipment, such as the high-performance liquid chromatograph and UV-visible spectrophotometer, were also compromised, showing altered system dates, lack of access controls, and no data backup. These actions violated the "Drug Administration Law of the People's Republic of China" and relevant Good Manufacturing Practice (GMP) regulations. Consequently, regulatory authorities mandated the immediate revocation of the company's GMP certificate, cessation of all production, a thorough investigation into the production and sales of injectable hepatocyte growth factor, a complete recall of all affected products from the market, and the initiation of further regulatory investigation.

Company: https://www.globalkeysolutions.net/companies/liaoning-yuhuang-pharmaceutical-co-ltd/49660a72-fb7e-4807-914a-571298b89952/