# China NMPA Inspection - Tianjin Zibo High Technology Co., Ltd. - June 23, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-zibo-high-technology-co-ltd/b6cd2c60-6200-4c86-b416-dc96e7092450/
Source feed: China

> China NMPA unannounced inspection for Tianjin Zibo High Technology Co., Ltd. published June 23, 2017. An unannounced inspection by the State Food and Drug Administration (SFDA) conducted from May 8-9, 2017, revealed critical non-compliance at Tianjin Z

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notice from the General Office of the State Administration of Radio, Film and Television on Urging Tianjin Zibo High Technology Co., Ltd. to Conduct Follow-up Inspections of Issues Discovered During Flight Inspections
- Company Name: Tianjin Zibo High Technology Co., Ltd.
- Publication Date: 2017-06-23
- Product Type: Device
- Summary: An unannounced inspection by the State Food and Drug Administration (SFDA) conducted from May 8-9, 2017, revealed critical non-compliance at Tianjin Zibo High-Tech Co., Ltd., a manufacturer of disposable bilirubin plasma perfusion devices. The inspection, carried out under the regulatory framework of the "Regulations on Unannounced Inspections of Drugs and Medical Devices" (SFDA Order No. 14) and the "Good Manufacturing Practice for Medical Devices," found that the company's Medical Device Production License had expired on September 1, 2016, and had not been renewed. Furthermore, the company had ceased all production activities, with its facility locked and no personnel present during the inspection. Inspectors also noted the absence of quality management system documentation or records on site, though some finished products and materials remained. As a direct consequence of these violations, Tianjin Zibo High-Tech Co., Ltd. is prohibited from resuming production. The company must first obtain a valid Medical Device Production License and secure verification from the Tianjin Municipal Market and Quality Supervision and Management Commission confirming it meets all relevant requirements. Local regulatory bodies are also mandated to supervise the proper handling and disposal of all remaining expired products and raw materials to ensure public safety.

Company: https://www.globalkeysolutions.net/companies/tianjin-zibo-high-technology-co-ltd/4660706c-5e27-4a96-b0c3-8dc5a0225a1d/