# China NMPA Inspection - Yake Medical Products (Beijing) Co., Ltd. - November 03, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/yake-medical-products-beijing-co-ltd/6831d99e-3b0d-4660-8de9-51cbc0dc058e/
Source feed: China

> China NMPA unannounced inspection for Yake Medical Products (Beijing) Co., Ltd. published November 03, 2017. Yake Medical Products (Beijing) Co., Ltd. underwent an unannounced compliance inspection from September 11-13, 2017, focusing on their Medical Absorba

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Yake Medical Products (Beijing) Co., Ltd.
- Company Name: Yake Medical Products (Beijing) Co., Ltd.
- Publication Date: 2017-11-03
- Product Type: Device
- Summary: Yake Medical Products (Beijing) Co., Ltd. underwent an unannounced compliance inspection from September 11-13, 2017, focusing on their Medical Absorbable Sutures. The inspection was based on the Good Manufacturing Practice for Medical Devices, particularly the Appendix for Implantable Medical Devices. One serious deficiency was identified, primarily concerning the sterilization process. This included incomplete process documentation, insufficient re-validation procedures for ethylene oxide sterilization equipment, and a lack of critical biological indicator information, failing to meet required standards. Additionally, twelve general deficiencies were noted across the company's operations. These encompassed inadequate sealing machine process control and equipment performance, poor record-keeping for UV disinfection, use of inaccurate measurement instruments for product quality, inconsistencies between documented and actual quality control procedures (e.g., document control, incoming material inspection), and a lack of proper identification and traceability in storage areas for finished products and raw materials. Issues also included unsubstantiated storage conditions, uncalibrated monitoring instruments, and lapses in cleanroom practices and sterilization record accuracy. As a result, Yake Medical Products (Beijing) Co., Ltd. was ordered to immediately suspend production for rectification. The company must assess product safety risks, recall any potentially unsafe products, and ensure compliance with the "Regulations on the Supervision and Administration of Medical Devices." The rectification status and regulatory actions will be publicly disclosed.

Company: https://www.globalkeysolutions.net/companies/yake-medical-products-beijing-co-ltd/1539dce7-a4dd-4325-baee-b4bb7ecf3e26/