# China NMPA Inspection - Wuhan Seres Medical Technology Co., Ltd. - November 21, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/wuhan-seres-medical-technology-co-ltd/965ffd4b-ba69-4f15-8726-75604ade1b77/
Source feed: China

> China NMPA unannounced inspection for Wuhan Seres Medical Technology Co., Ltd. published November 21, 2017. Wuhan Seres Medical Technology Co., Ltd. underwent an unannounced compliance inspection on October 17, 2017, based on the regulatory framework of Good

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Wuhan Seres Medical Technology Co., Ltd.
- Company Name: Wuhan Seres Medical Technology Co., Ltd.
- Publication Date: 2017-11-21
- Product Type: Device
- Summary: Wuhan Seres Medical Technology Co., Ltd. underwent an unannounced compliance inspection on October 17, 2017, based on the regulatory framework of Good Manufacturing Practice for Medical Devices. The inspection identified five significant deficiencies in the company's operations and quality management system.

Key violations included the improper storage of returned products, specifically a Chemiluminescence Immunoassay Analyzer and a Urine Formed Element Analyzer, which were not stored separately as required. Additionally, a purchase receipt was found to lack completed acceptance results, indicating a procedural lapse. A critical finding was the presence of expired Activated Partial Thromboplastin Time (APTT) Assay Reagent within the qualified cold storage area. The inspection also revealed a discrepancy between inventory records and actual stock for Blood Gas Analyzers, with 11 units purchased and 4 sold, yet only 6 physically accounted for. Lastly, a sales outbound verification form for the product "CD64 PE" lacked a medical device registration or filing certificate number, which the company was unable to provide during the inspection.

As a result, the Hubei Provincial Food and Drug Administration has ordered Wuhan Seres Medical Technology Co., Ltd. to rectify these issues within a specified period. The provincial authority will conduct follow-up inspections to ensure compliance and will report the findings to the national Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/wuhan-seres-medical-technology-co-ltd/e1d788c0-ce39-4fbf-b791-0ce0b5d370e5/