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

Source: https://www.globalkeysolutions.net/records/china_inspection/heilongjiang-liaoyuan-technology-co-ltd/e66a305d-0a96-4ee2-8104-c066e769d6a9/
Source feed: China

> China NMPA unannounced inspection for Heilongjiang Liaoyuan Technology Co., Ltd. published November 03, 2017. Heilongjiang Liaoyuan Technology Co., Ltd. underwent an unannounced compliance inspection by the FDA/NMPA from September 26-27, 2017, focusing on its 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Flight Inspection Report on Heilongjiang Liaoyuan Technology Co., Ltd.
- Company Name: Heilongjiang Liaoyuan Technology Co., Ltd.
- Publication Date: 2017-11-03
- Product Type: Device
- Summary: Heilongjiang Liaoyuan Technology Co., Ltd. underwent an unannounced compliance inspection by the FDA/NMPA from September 26-27, 2017, focusing on its Medical Polyethylene Glycol Berberine Solution production. The inspection, based on the Good Manufacturing Practice for Medical Devices and its Implantable Medical Devices Appendix, revealed significant quality management deficiencies.

Four serious defects were identified. These included traceability failures due to mismatched waste records for batch 20170725, critical issues in the testing laboratory such as missing reference standards and unverified distilled water, absence of incoming inspection records for berberine hydrochloride for the same batch, and the lack of a biosafety cabinet in the positive control room.

Additionally, eighteen general deficiencies highlighted systemic issues. These encompassed unverified purification system modifications, inadequate cleaning validation and record-keeping for equipment, poor control over raw material storage, and a lack of proper calibration and maintenance records for various instruments and cleanroom utilities. Supplier evaluation was found to be simplistic, product identification procedures were insufficient, and cleanroom garment management was substandard. Concerns also arose regarding process water quality control, undefined storage conditions for intermediate products, and a failure to maintain comprehensive distribution and testing records, including original sample test data.

As a result, Heilongjiang Liaoyuan Technology Co., Ltd. was ordered to immediately suspend production for rectification. The company must address all identified deficiencies, assess product safety risks, and recall any potentially hazardous products. Resumption of production is contingent upon completing all rectification and passing a subsequent follow-up inspection by the provincial administration. The inspection findings and regulatory actions are to be publicly disclosed.

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