# China NMPA Inspection - Inner Mongolia Aizhong Medical Imaging Co., Ltd. - December 22, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/inner-mongolia-aizhong-medical-imaging-co-ltd/8fe4ef8e-e853-4537-b3cb-3937db834d8b/
Source feed: China

> China NMPA unannounced inspection for Inner Mongolia Aizhong Medical Imaging Co., Ltd. published December 22, 2017. An unannounced inspection of Inner Mongolia Aizhong Medical Imaging Co., Ltd., producer of a gastrointestinal imaging agent, was conducted on November

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Inner Mongolia Aizhong Medical Imaging Co., Ltd.
- Company Name: Inner Mongolia Aizhong Medical Imaging Co., Ltd.
- Publication Date: 2017-12-22
- Product Type: Device
- Summary: An unannounced inspection of Inner Mongolia Aizhong Medical Imaging Co., Ltd., producer of a gastrointestinal imaging agent, was conducted on November 23-24, 2017. The inspection, based on Good Manufacturing Practice for Medical Devices, uncovered significant quality management deficiencies.

Four serious defects were identified, including the absence of required positive control testing facilities and biosafety cabinets, a lack of quality agreements with critical suppliers (liquid paraffin and PET preforms), inconsistencies between finished product and purified water testing SOPs and national pharmacopoeia standards, and discrepancies in non-conforming product records. Additionally, eight general deficiencies were noted, encompassing issues such as inadequate assessment of the quality manager's qualifications, facility design flaws (e.g., purified water system placement, lack of clean weighing areas), poor warehouse management (crowding, missing location cards), unconfirmed sterilization parameters, and insufficient equipment calibration and change control processes.

As a result, Inner Mongolia Aizhong Medical Imaging Co., Ltd. has been ordered to immediately suspend production for rectification, assess product safety risks, and initiate recalls for potentially hazardous products. The company must also address regulatory violations and can only resume production after all deficiencies are rectified and a follow-up inspection is successfully passed.

Company: https://www.globalkeysolutions.net/companies/inner-mongolia-aizhong-medical-imaging-co-ltd/048b4fde-3017-4137-ad9e-2292d40393d5/