# China NMPA Inspection - Guangdong Baihe Medical Technology Co., Ltd - October 11, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guangdong-baihe-medical-technology-co-ltd/9a90ad7e-4908-477a-a8ce-da6b4769162e/
Source feed: China

> China NMPA unannounced inspection for Guangdong Baihe Medical Technology Co., Ltd published October 11, 2018. An unannounced inspection of Guangdong Baihe Medical Technology Co., Ltd., conducted from September 4-5, 2018, identified significant non-compliance w

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guangdong Baihe Medical Technology Co., Ltd.
- Company Name: Guangdong Baihe Medical Technology Co., Ltd
- Publication Date: 2018-10-11
- Product Type: Device
- Summary: An unannounced inspection of Guangdong Baihe Medical Technology Co., Ltd., conducted from September 4-5, 2018, identified significant non-compliance with *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*. The company, a manufacturer of Disposable Sterile Central Venous Catheters, was found to have one serious defect and thirteen general deficiencies.
The serious violation involved critical failures in maintaining aseptic conditions, specifically inadequate sealing and lack of proper pressure gradients between Class 10,000 and Class 100,000 cleanroom packaging workshops, creating a high risk of contamination.
General deficiencies included widespread issues with documentation and record-keeping, such as missing HEPA filter replacement logs, absent equipment usage records, and improper change control procedures for process parameters and operating instructions. There were also inconsistencies in handling non-conforming products, with some reworked and others scrapped without clear, validated processes. Furthermore, significant lapses in environmental control were noted, including insufficient cleanroom pressure gradients, co-mingling of personnel and logistics, lack of post-shutdown environmental monitoring, and introduction of unpurified raw materials into clean areas.
Consequently, regulatory authorities mandated immediate suspension of production for rectification. The company is required to assess product safety risks, recall any hazardous products, and publicize its remediation efforts. Production can only resume after all deficiencies are thoroughly addressed and verified through a successful follow-up inspection.

Company: https://www.globalkeysolutions.net/companies/guangdong-baihe-medical-technology-co-ltd/79d2e901-9843-48f0-8311-ef9f3c32b884/