# China NMPA Inspection - Yangzhou Xiaokang Medical Equipment Co., Ltd. - September 29, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/yangzhou-xiaokang-medical-equipment-co-ltd/2f8471ae-13d8-430b-9920-bfdae4145ada/
Source feed: China

> China NMPA unannounced inspection for Yangzhou Xiaokang Medical Equipment Co., Ltd. published September 29, 2018. An unannounced inspection of Changzhou Xiaochun Medical Equipment Co., Ltd., a manufacturer of Disposable Sterile Vaginal Speculums, was conducted fro

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Changzhou Xiaochun Medical Equipment Co., Ltd.
- Company Name: Yangzhou Xiaokang Medical Equipment Co., Ltd.
- Publication Date: 2018-09-29
- Product Type: Device
- Summary: An unannounced inspection of Changzhou Xiaochun Medical Equipment Co., Ltd., a manufacturer of Disposable Sterile Vaginal Speculums, was conducted from September 4-5, 2018. The inspection, based on the Good Manufacturing Practice for Medical Devices and its appendix for sterile devices, identified significant deficiencies across multiple areas.

Key violations included a damaged cleanroom floor, inadequate pest prevention in raw material and finished product warehouses, and poor warehouse organization, characterized by a lack of clear area definitions, excessive stacking, and absence of location tags. Equipment-related issues included packaging sealing machines lacking status indicators and critical instruments like differential pressure gauges and sterilizer pressure gauges being uncalibrated or expired. The company also failed to provide a product quality certificate for a polystyrene batch, and both products on the production floor and laboratory instruments were unlabeled.

Specific sterile manufacturing concerns involved the absence of unpacking and buffer zones for material transfer in clean areas and compromised seals on the cleanroom floor. Critically, the sterilization process control system showed flaws: procedures incorrectly described chemical indicator card color changes, and the presence of both unsterilized and sterilized indicator cards at the site for covering packaging could lead to confusion. Regulations for post-sterilization analytical environment and time were also found to be vague.

As a result, the company is required to promptly rectify these issues, assess product safety risks, and initiate product recalls for any items posing hazards. Follow-up inspections may occur, and rectification details must be reported to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/yangzhou-xiaokang-medical-equipment-co-ltd/915199f9-1d76-4de3-8d74-cdcd5fbaca36/