# China NMPA Inspection - Changzhou Huayue Minimally Invasive Medical Devices Co., Ltd. - October 30, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/changzhou-huayue-minimally-invasive-medical-devices-co-ltd/eab09975-b545-4947-9208-2ed155ae3ad0/
Source feed: China

> China NMPA unannounced inspection for Changzhou Huayue Minimally Invasive Medical Devices Co., Ltd. published October 30, 2017. An unannounced inspection of Changzhou Huayue Minimally Invasive Medical Devices Co., Ltd. was conducted from September 28-29, 2017, to assess complia

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Changzhou Huayue Minimally Invasive Medical Devices Co., Ltd.
- Company Name: Changzhou Huayue Minimally Invasive Medical Devices Co., Ltd.
- Publication Date: 2017-10-30
- Product Type: Device
- Summary: An unannounced inspection of Changzhou Huayue Minimally Invasive Medical Devices Co., Ltd. was conducted from September 28-29, 2017, to assess compliance with Good Manufacturing Practice for Medical Devices. The inspection revealed seven general deficiencies primarily related to quality management and production controls.

Key violations included inadequate documentation for cleaning, disinfection, and intermediate product release processes. The company failed to update raw material supplier evaluations with new drug application approvals in accordance with the 2015 Chinese Pharmacopoeia. Deficiencies were also noted in quality control, with no acceptance standards or quality evaluation for microbiological testing culture media, and a lack of effective data analysis for microbial monitoring of packaging materials and the environment.

Furthermore, issues in facility control were observed, such as the absence of differential pressure monitoring devices in cleanrooms and a lack of status markings for sterilized packaging materials. Critical quality control equipment, specifically the particulate matter detector, lacked calibration certificates and records as required by testing standards.

As a result, the Jiangsu Provincial Food and Drug Administration ordered the company to rectify these issues within a specified timeframe, assess product safety risks, and initiate product recalls if safety hazards are identified. Follow-up inspections may be conducted, and the company must report its rectification progress to the Medical Device Supervision Department.

Company: https://www.globalkeysolutions.net/companies/changzhou-huayue-minimally-invasive-medical-devices-co-ltd/0bd9711e-d65b-4d21-9bcf-eb8e0277223b/