# China NMPA Inspection - Zibo Kangbei Medical Equipment Co., Ltd. - July 07, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/zibo-kangbei-medical-equipment-co-ltd/0ead3ac0-9ca3-456b-ab8a-50481cf921db/
Source feed: China

> China NMPA unannounced inspection for Zibo Kangbei Medical Equipment Co., Ltd. published July 07, 2017. The State Food and Drug Administration (SFDA) conducted unannounced inspections of medical device manufacturers in June 2017, enforcing the "Regulatio

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notice from the General Office of the State Administration of Radio and Television on Urging Zibo Kangbei Medical Device Co., Ltd. and Shandong Qiaopai Group Co., Ltd. to Rectify Problems Found During Flight Inspections
- Company Name: Zibo Kangbei Medical Equipment Co., Ltd.
- Publication Date: 2017-07-07
- Product Type: Device
- Summary: The State Food and Drug Administration (SFDA) conducted unannounced inspections of medical device manufacturers in June 2017, enforcing the "Regulations on Unannounced Inspections of Drugs and Medical Devices" and "Good Manufacturing Practice for Medical Devices" (GMP), particularly for sterile devices. Zibo Kangbei Medical Device Co., Ltd. was inspected from June 6-7, 2017, and Shandong Qiaopai Group Co., Ltd. from June 8-9, 2017. 

Zibo Kangbei Medical Device Co., Ltd., producing Disposable Hemoperfusion Devices, received eight general defect findings. Significant issues included an unnumbered and inconsistent management representative appointment document, an inadequate raw material warehouse with leaks and standing water, an uncalibrated pressure gauge, incorrect quantities in production records, and an electronic balance lacking shockproof measures. Furthermore, initial sterile packaging was not conducted in a cleanroom, and material consistency with biological evaluations could not be verified.

While the specific violations for Shandong Qiaopai Group Co., Ltd. were not fully detailed in the provided content, both companies are mandated to rectify all identified issues promptly. Required actions include timed rectification, follow-up inspections to assess product safety, and potential product recalls under the "Regulations on the Recall Management of Medical Devices." The provincial administration must also enhance daily supervision and inspection intensity to ensure strict adherence to GMP and product safety.

Company: https://www.globalkeysolutions.net/companies/zibo-kangbei-medical-equipment-co-ltd/35f6310c-94bc-471b-99d9-e205f9e11ca5/