# China NMPA Inspection - Shanxi Xinhuamei Medical Equipment Co., Ltd. - July 16, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shanxi-xinhuamei-medical-equipment-co-ltd/f165f3c9-8c60-4086-a09c-3112ed0a58cc/
Source feed: China

> China NMPA unannounced inspection for Shanxi Xinhuamei Medical Equipment Co., Ltd. published July 16, 2018. An unannounced inspection of Shanxi Xinhua Mei Medical Device Co., Ltd., conducted on June 26-27, 2018, revealed 18 minor deficiencies against the *Go

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shanxi Xinhuamei Medical Device Co., Ltd.
- Company Name: Shanxi Xinhuamei Medical Equipment Co., Ltd.
- Publication Date: 2018-07-16
- Product Type: Device
- Summary: An unannounced inspection of Shanxi Xinhua Mei Medical Device Co., Ltd., conducted on June 26-27, 2018, revealed 18 minor deficiencies against the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*. The company, a manufacturer of Disposable Sterile Self-Destructing Syringes, exhibited several systemic issues.

Key violations included inadequate training documentation for new personnel and significant cleanroom control problems, such as direct connections between non-clean and clean areas, malfunctioning air filters, and a lack of documented HEPA filter replacements and post-shutdown verification. Documentation deficiencies were noted in the quality manual inconsistencies and incomplete cleanroom control procedures. The company also failed to follow change control protocols for material and labeling updates.

Supplier management was problematic, lacking prioritization for critical material suppliers, essential biological evaluation data for key components, and clear quality agreement specifications for directly assembled unsterilized parts. Furthermore, process validation for packaging speed and sterilization processes was insufficient, with missing data and risk analysis. Finally, poor material status identification in production areas and inadequate clearing management for unused materials posed contamination risks.

Shanxi Xinhua Mei Medical Device Co., Ltd. is required to address these deficiencies, identify root causes, assess safety risks, and implement corrective actions to ensure product quality and safety compliance.

Company: https://www.globalkeysolutions.net/companies/shanxi-xinhuamei-medical-equipment-co-ltd/d1ba7378-1fa1-49a0-8698-b54f775edc60/