# China NMPA Inspection - Inner Mongolia Aizhong Medical Imaging Co., Ltd. - December 18, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/inner-mongolia-aizhong-medical-imaging-co-ltd/c1318632-355d-4230-9ca0-565761fced65/
Source feed: China

> China NMPA unannounced inspection for Inner Mongolia Aizhong Medical Imaging Co., Ltd. published December 18, 2017. A surprise inspection by the State Food and Drug Administration (SFDA) of Inner Mongolia Aizhong Medical Imaging Co., Ltd., announced on December 14, 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 207 of 2017 from the State Administration of Radio and Television regarding the suspension of production and rectification of Inner Mongolia Aizhong Medical Imaging Co., Ltd.
- Company Name: Inner Mongolia Aizhong Medical Imaging Co., Ltd.
- Publication Date: 2017-12-18
- Product Type: Device
- Summary: A surprise inspection by the State Food and Drug Administration (SFDA) of Inner Mongolia Aizhong Medical Imaging Co., Ltd., announced on December 14, 2017, uncovered critical deficiencies in the company's quality management system. Operating under the *Good Manufacturing Practice for Medical Devices*, the company failed to meet regulatory requirements across several key areas. Violations included inadequate plant design and facilities, such as improper cleanroom configurations and lack of essential testing equipment. Design and development processes were non-compliant, specifically regarding an unrecorded change in liquid paraffin grade from food-grade to pharmaceutical excipient-grade without proper verification. Procurement issues involved the absence of quality agreements with major raw material suppliers. Production management exhibited a failure to verify ultra-high temperature sterilization parameters, and quality control procedures for finished products and purified water were inconsistent with approved technical standards and pharmacopoeia requirements. Additionally, the company demonstrated poor control over non-conforming products, with discrepancies in records and a lack of proper review. Consequently, the SFDA has instructed the company to immediately cease production, rectify all identified issues, assess product safety risks, and recall any potentially hazardous products. Production may only resume after successful rectification and a follow-up inspection by the provincial food and drug administration, with legal action threatened for continued non-compliance with the *Regulations on the Supervision and Administration of Medical Devices*.

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