# China NMPA Inspection - Heilongjiang Liaoyuan Technology Co., Ltd. - November 03, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/heilongjiang-liaoyuan-technology-co-ltd/c0ae4ed9-7ed2-480f-89b2-a6e178aca130/
Source feed: China

> China NMPA unannounced inspection for Heilongjiang Liaoyuan Technology Co., Ltd. published November 03, 2017. On November 1, 2017, the State Food and Drug Administration (SFDA) announced findings from an unannounced inspection of Heilongjiang Liaoyuan Technolo

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 173 of 2017 from the State Administration of Taxation regarding the suspension of production and rectification of Heilongjiang Liaoyuan Technology Co., Ltd.
- Company Name: Heilongjiang Liaoyuan Technology Co., Ltd.
- Publication Date: 2017-11-03
- Product Type: Device
- Summary: On November 1, 2017, the State Food and Drug Administration (SFDA) announced findings from an unannounced inspection of Heilongjiang Liaoyuan Technology Co., Ltd., a producer of medical-grade polyethylene glycol berberine solution. The inspection revealed severe deficiencies across the company's quality management system, indicating non-compliance with Good Manufacturing Practice (GMP) for medical devices and related regulations. Key issues included an unverified purification system upgrade and inadequate cleanroom cleaning procedures. Document management was critically flawed, lacking records for equipment usage, maintenance, and sample retention. Procurement processes failed to establish acceptance criteria for initial packaging material contamination. Production records showed discrepancies and lacked specific sterilization parameters, hindering traceability. Extensive quality control deficiencies were identified, encompassing the absence of reference standards, inadequate raw material inspection, deficient testing laboratory facilities, insufficient process water monitoring, and poorly defined intermediate product storage with a lack of contamination monitoring. As a result, Heilongjiang Liaoyuan Technology Co., Ltd. has been ordered to immediately cease production and implement comprehensive rectification. The company must also assess product safety risks and recall any hazardous products. Production may only resume after successful rectification and a follow-up inspection by provincial authorities. Non-compliance will lead to serious legal action.

Company: https://www.globalkeysolutions.net/companies/heilongjiang-liaoyuan-technology-co-ltd/d36868ba-c0d4-47f0-9f4a-2105910e2ff8/