# China NMPA Inspection - Henan Yubei Medical Supplies Co., Ltd. - July 18, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/henan-yubei-medical-supplies-co-ltd/46e31682-a432-4be2-a393-48c0c5bf524e/
Source feed: China

> China NMPA unannounced inspection for Henan Yubei Medical Supplies Co., Ltd. published July 18, 2018. An unannounced inspection of Henan Yubei Medical Supplies Co., Ltd. was conducted from June 26-27, 2018, focusing on their Disposable Sterile Vaginal 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Henan Yubei Medical Supplies Co., Ltd.
- Company Name: Henan Yubei Medical Supplies Co., Ltd.
- Publication Date: 2018-07-18
- Product Type: Device
- Summary: An unannounced inspection of Henan Yubei Medical Supplies Co., Ltd. was conducted from June 26-27, 2018, focusing on their Disposable Sterile Vaginal Speculum. The inspection, based on *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*, revealed six serious and eleven general defects.

Key serious violations included the absence of equipment for "deformation resistance" testing and a failure to conduct safety or risk assessments for changes in raw materials, with multiple polymer types used despite design documents only specifying polypropylene. Furthermore, raw material purchase records and batch production records were untraceable, lacking crucial supplier and batch information. Significant issues also arose with product testing, including missing original inspection records, reliance on obsolete standards, and inconsistent sterility test methods. Most critically, a batch of products was released without documented evidence of complete sterilization, lacking ethylene oxide indicator cards or certificates.

General deficiencies encompassed inadequate facility maintenance (lighting, pest control), discrepancies in equipment usage records, and the use of uncontrolled or outdated quality control documents. There were also notable failures in supplier management, with no audit or evaluation records for raw material changes, and pervasive issues with product and material labeling, leading to inventory discrepancies.

Henan Yubei Medical Supplies Co., Ltd. is required to assume primary responsibility for quality and safety, conduct thorough root cause analyses, assess safety risks, and implement necessary corrective actions to ensure compliance and control risks.

Company: https://www.globalkeysolutions.net/companies/henan-yubei-medical-supplies-co-ltd/7d46d4f2-90c7-4e70-a214-ae2938e03110/