# China NMPA Inspection - Henan Xinpiaoan High-Tech Co., Ltd. - November 03, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/henan-xinpiaoan-high-tech-co-ltd/5c07c51f-38a1-4508-be53-e88803b5f7fe/
Source feed: China

> China NMPA unannounced inspection for Henan Xinpiaoan High-Tech Co., Ltd. published November 03, 2017. An unannounced inspection of Henan Xinpiaoan High-Tech Co., Ltd., conducted from September 14-15, 2017, revealed significant non-compliance with medic

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Flight Inspection of Henan Xinpiaoan High-Tech Co., Ltd.
- Company Name: Henan Xinpiaoan High-Tech Co., Ltd.
- Publication Date: 2017-11-03
- Product Type: Device
- Summary: An unannounced inspection of Henan Xinpiaoan High-Tech Co., Ltd., conducted from September 14-15, 2017, revealed significant non-compliance with medical device manufacturing regulations. The purpose was to assess adherence to the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices. The inspection identified five serious defects. These included insufficient production equipment capacity for declared output (e.g., using a small balance and basic cooking equipment for large-scale production), an unapproved quality manual lacking essential signatures, the absence of a procurement agreement for critical raw materials like gauze blocks, inconsistencies between process flow charts and work instructions, and a critical lack of traceability for raw materials such as medical petroleum jelly. Additionally, five general defects were noted, encompassing issues with the cleanroom environment (e.g., ventilation, damaged differential pressure gauges, obstructed return air vents), inadequate insect prevention in changing rooms, an incomplete qualified supplier list for gauze pads, missing or uncontrolled inspection records for incoming raw materials, and the absence of test records for air conditioning purification system restarts. Consequently, the Henan Provincial Food and Drug Administration mandated immediate production suspension for rectification, in accordance with the 'Regulations on the Supervision and Administration of Medical Devices.' The company is required to assess product safety risks, recall any potentially unsafe products, and address all identified deficiencies. Production can only resume after all rectifications are complete and a follow-up inspection is successfully passed. The Provincial Administration will publish the company's rectification status and regulatory actions.

Company: https://www.globalkeysolutions.net/companies/henan-xinpiaoan-high-tech-co-ltd/6d8359b1-81b0-43ce-8e4f-8a4927ea06aa/