# China NMPA Inspection - Beijing BaiRen Medical Technology Co., Ltd. - May 23, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/beijing-bairen-medical-technology-co-ltd/653831f6-4511-4871-8801-5d05ed30752b
Source feed: China

> China NMPA unannounced inspection for Beijing BaiRen Medical Technology Co., Ltd. published May 23, 2018. Beijing BaiRen Medical Technology Co., Ltd. was subject to an unannounced compliance inspection from April 16th to April 18th, 2018. The inspection, c

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Beijing BaiRen Medical Technology Co., Ltd.
- Company Name: Beijing BaiRen Medical Technology Co., Ltd.
- Publication Date: 2018-05-23
- Product Type: Device
- Summary: Beijing BaiRen Medical Technology Co., Ltd. was subject to an unannounced compliance inspection from April 16th to April 18th, 2018. The inspection, conducted under the Good Manufacturing Practice for Medical Devices (GMP) with a focus on implantable devices like artificial biological heart valves, revealed nine general deficiencies. Main issues included improper storage of raw materials, lack of maintenance procedures for manufacturing equipment, and significant inconsistencies in production records, such as unrecorded processing times and discrepancies between instructions and audit logs. Inventory discrepancies were noted where ledger balances did not match physical stock. The company also failed to provide standard operating procedures for material procurement, software verification reports for a CNC machine, and verification reports for residual processing chemicals like formaldehyde. Furthermore, quality control responsibilities for sample retention were unclear, and environmental controls were inadequate, with high humidity recorded in a clean room. Aseptic testing was found to be conducted in a production clean bench rather than a dedicated testing environment. The Beijing Municipal Food and Drug Administration requires the company to rectify these deficiencies, assess product safety risks, and potentially recall hazardous products. Follow-up inspections are anticipated, and a report on the rectification must be submitted to the national medical device supervision department.

Company: https://www.globalkeysolutions.net/companies/beijing-bairen-medical-technology-co-ltd/932c16e5-86d6-4c7f-936e-60380ec04acf