# China NMPA Inspection - Anhui Jiren Pharmaceutical Co., Ltd. - June 09, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/anhui-jiren-pharmaceutical-co-ltd/77e274e4-0580-4e52-850f-3a62213c6a2a/
Source feed: China

> China NMPA unannounced inspection for Anhui Jiren Pharmaceutical Co., Ltd. published June 09, 2017. An unannounced inspection of Anhui Jiren Pharmaceutical Co., Ltd., conducted from January 10-12, 2017, by the State Food and Drug Administration, reve

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Anhui Jiren Pharmaceutical Co., Ltd.
- Company Name: Anhui Jiren Pharmaceutical Co., Ltd.
- Publication Date: 2017-06-09
- Product Type: Drugs
- Summary: An unannounced inspection of Anhui Jiren Pharmaceutical Co., Ltd., conducted from January 10-12, 2017, by the State Food and Drug Administration, revealed severe regulatory non-compliance. The main violations centered on unauthorized alterations to the production of Yankening tablets, including changes to the manufacturing process, formula, and raw material quantities. Specifically, the company used Phellodendron bark powder instead of the prescribed extract method, adjusted dosages of critical ingredients like Phellodendron bark, Rhubarb, and Coptis chinensis, and added unauthorized excipients such as starch and dextrin.

Further issues included chaotic material management, with inconsistencies across inventory records, warehouse cards, and financial documents. Significant concerns were also identified regarding the reliability of test data, marked by discrepancies in chromatographic reports, evidence of deleted electronic data, and the absence of required equipment for recorded microscopic measurements. Compounding these issues, the company maintained two sets of batch production records: one reflecting the actual, non-compliant process, and another fabricated to appear compliant with national standards.

These actions violated the "Drug Administration Law of the People's Republic of China" and relevant Good Manufacturing Practice (GMP) regulations. As a result, the State Food and Drug Administration ordered the Anhui Provincial Food and Drug Administration to revoke the company's GMP certificate.

Company: https://www.globalkeysolutions.net/companies/anhui-jiren-pharmaceutical-co-ltd/dfd92d72-c861-4ead-bfbb-4019a9d98c26/