# China NMPA Inspection - Hubei Kangyuan Pharmaceutical Co., Ltd. - February 23, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-kangyuan-pharmaceutical-co-ltd/b7817a73-494d-49dc-be11-57185a08c3a0
Source feed: China

> China NMPA unannounced inspection for Hubei Kangyuan Pharmaceutical Co., Ltd. published February 23, 2017. Hubei Kangyuan Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration Verification Center and H

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hubei Kangyuan Pharmaceutical Co., Ltd.
- Company Name: Hubei Kangyuan Pharmaceutical Co., Ltd.
- Publication Date: 2017-02-23
- Product Type: Drugs
- Summary: Hubei Kangyuan Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration Verification Center and Hubei Provincial FDA from January 10-13, 2017. The inspection uncovered critical non-compliance issues. The company was found producing gelling agents and syrups, including various gelatins and concentrated vitamin B1 phosphate syrup, in workshops that lacked Good Manufacturing Practice (GMP) certification, encompassing newly renovated facilities.

Key violations included manufacturing and selling products without proper certification, using altered or counterfeit batch numbers. Approximately 45,000 kg of uncertified gelatin products were sold, with no corresponding batch production or inspection records, and a complete absence of required quality testing. Production personnel admitted to fabricating batch numbers to evade regulatory oversight. Additionally, the company recycled returned products, repackaging them in uncertified facilities and re-labeling them with new batch numbers.

A significant finding was Hubei Kangyuan's maintenance of three sets of internal accounts and production records to circumvent inspections, showing inconsistencies in raw material usage and batch information. The company's responsible person acknowledged these multiple record-keeping systems, intended to manage penalties for substandard samples and market pricing, without providing complete documentation for verification. These severe findings necessitate immediate cessation of all non-compliant production and sales, comprehensive implementation of robust quality control measures, and establishment of transparent, accurate record-keeping practices to align with pharmaceutical regulations.

Company: https://www.globalkeysolutions.net/companies/hubei-kangyuan-pharmaceutical-co-ltd/d60cb2c8-07fc-49e6-a4cd-6c8e8404e1c4