# China NMPA Inspection - Tianjin Southeast Hengsheng Medical Materials Co., Ltd. - July 16, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-southeast-hengsheng-medical-materials-co-ltd/1037a6da-ffce-4fdb-bac8-79b021c83ed8/
Source feed: China

> China NMPA unannounced inspection for Tianjin Southeast Hengsheng Medical Materials Co., Ltd. published July 16, 2018. An unannounced, cause-based inspection of Tianjin Southeast Hengsheng Medical Materials Co., Ltd. was conducted on June 25-26, 2018, based on Good Man

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Tianjin Southeast Hengsheng Medical Materials Co., Ltd.
- Company Name: Tianjin Southeast Hengsheng Medical Materials Co., Ltd.
- Publication Date: 2018-07-16
- Product Type: Device
- Summary: An unannounced, cause-based inspection of Tianjin Southeast Hengsheng Medical Materials Co., Ltd. was conducted on June 25-26, 2018, based on Good Manufacturing Practice for Medical Devices. The inspection revealed that the company, which manufactures Medical Absorbable Synthetic Sutures, was in a complete state of production stoppage. The factory, equipment, and personnel were all idle or laid off. This finding corroborated the "Statement of Production Suspension" submitted by the company on May 21, 2018, indicating production ceased on May 28, 2018. Despite having valid product registration and a production license, the company was not operational, which constituted the primary issue identified.

To resume operations, Tianjin Southeast Hengsheng Medical Materials Co., Ltd. is required to submit a written report to the Tianjin Municipal Market and Quality Supervision and Management Commission. Production can only recommence after this commission inspects the facility and confirms compliance with regulatory requirements. Furthermore, the Tianjin Municipal Commission must promptly inform the National Medical Products Administration (NMPA) of any production resumption. The Tianjin Municipal Commission is also tasked with monitoring the quality and safety of the company's marketed products and ensuring the company upholds its primary responsibility for product quality and safety throughout the products' shelf life.

Company: https://www.globalkeysolutions.net/companies/tianjin-southeast-hengsheng-medical-materials-co-ltd/821a3297-c6ca-4f19-8752-bd5858782dd3/