# China NMPA Inspection - Lifetech  Scientific (Shenzhen) Corporation Ltd - August 04, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/lifetech-scientific-shenzhen-corporation-ltd/fd5fb9e9-2904-4e88-a3d9-9f2675254630/
Source feed: China

> China NMPA unannounced inspection for Lifetech  Scientific (Shenzhen) Corporation Ltd published August 04, 2017. Lifetech Scientific (Shenzhen) Co., Ltd. was subject to an unannounced compliance inspection from July 20-21, 2017, for its Vena Cava Filter product. 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Lifetech Scientific (Shenzhen) Co., Ltd.
- Company Name: Lifetech  Scientific (Shenzhen) Corporation Ltd
- Publication Date: 2017-08-04
- Product Type: Device
- Summary: Lifetech Scientific (Shenzhen) Co., Ltd. was subject to an unannounced compliance inspection from July 20-21, 2017, for its Vena Cava Filter product. The inspection was conducted under the regulatory framework of the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Implantable Medical Devices*. A total of ten general defects were identified, highlighting several deviations from established quality and safety standards.

Key issues included improper storage of semi-finished products affecting cleanroom air supply, inconsistent equipment status labeling, and discrepancies in cleanroom environmental monitoring protocols. There were also failures to adhere to internal procedures for purified water batch numbering and conflicting cleanroom environment requirements for key raw material suppliers. Infrastructure deficiencies were noted, such as a pass-through window lacking a differential pressure indicator and uncleaned floor drains without specified cleaning regulations. Operational shortcomings extended to the maintenance of process water filters and hygiene in sterile areas, along with a critical failure to retain required samples per sterilization batch.

In response, the Guangdong Provincial Food and Drug Administration has ordered Lifetech Scientific to rectify all identified problems within a specified timeframe. The company is mandated to assess product safety risks, recall any products deemed hazardous, and report all corrective actions to the Medical Device Supervision Department of the State Administration for Market Regulation. Follow-up inspections may be conducted to confirm compliance.

Company: https://www.globalkeysolutions.net/companies/lifetech-scientific-shenzhen-corporation-ltd/25c847c9-b9db-41da-b4a8-cc1efacf5e80/