# China NMPA Inspection - Jiangsu Bolangsens Medical Device Co., Ltd. - August 23, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-bolangsens-medical-device-co-ltd/df4b53fa-9480-4326-aca9-9cf9b9bd8218/
Source feed: China

> China NMPA unannounced inspection for Jiangsu Bolangsens Medical Device Co., Ltd. published August 23, 2018. An unannounced NMPA inspection of Jiangsu Bolang Sens Medical Device Co., Ltd. was conducted from June 5-6, 2018, based on the Good Manufacturing Prac

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangsu Bolangsens Medical Device Co., Ltd.
- Company Name: Jiangsu Bolangsens Medical Device Co., Ltd.
- Publication Date: 2018-08-23
- Product Type: Device
- Summary: An unannounced NMPA inspection of Jiangsu Bolang Sens Medical Device Co., Ltd. was conducted from June 5-6, 2018, based on the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices. The inspection revealed two serious and seventeen general deficiencies related to the company's quality system and manufacturing processes for disposable circular anastomosing devices for laparoscopy. The serious deficiencies included critical issues with product release and testing. Specifically, the company used sterilization substitutes for EO residue and sterility testing without adequately defined procedures for these substitutes. Furthermore, product release conditions and criteria were unclear, and finished product inspection procedures lacked specification for crucial performance indicators like dimensions, suture formation, and sealing. Process inspection results were improperly used to substitute for finished product inspections, and release documentation showed inconsistencies and missing approvals. General deficiencies highlighted broader systemic weaknesses, including inadequate control over storage area management, inconsistent record-keeping, and a failure to adhere to design and development change procedures following regulatory updates. Issues were also noted in cleanroom practices, inventory accuracy, and the completeness of production and sterilization records. The company is required to take full responsibility for product quality and safety, investigate the root causes of these deficiencies, assess associated safety risks, and implement necessary corrective actions to ensure compliance and control risks.

Company: https://www.globalkeysolutions.net/companies/jiangsu-bolangsens-medical-device-co-ltd/5394ebc0-69f0-4165-934c-89084a1105ba/