# China NMPA Inspection - Guanhao Biotech Co., Ltd. - August 04, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/guanhao-biotech-co-ltd/db2264ed-e3ba-49f5-a04f-4c721e8f0481/
Source feed: China

> China NMPA unannounced inspection for Guanhao Biotech Co., Ltd. published August 04, 2017. An unannounced inspection of Guanhao Biotech Co., Ltd. was conducted by the FDA NMPA from July 18-19, 2017, focusing on compliance with the *Good Manu

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guanhao Biotech Co., Ltd.
- Company Name: Guanhao Biotech Co., Ltd.
- Publication Date: 2017-08-04
- Product Type: Device
- Summary: An unannounced inspection of Guanhao Biotech Co., Ltd. was conducted by the FDA NMPA from July 18-19, 2017, focusing on compliance with the *Good Manufacturing Practice for Medical Devices* and its appendix for implantable devices. The inspection revealed seven general deficiencies. Key issues included the absence of temperature and humidity records in the chemical reagent warehouse, incomplete document control for a critical testing procedure, and deficiencies in record-keeping for a summary sheet and production processes, specifically lacking details on preservation reagents and soaking times for the Thoracic and General Surgical Repair Membrane. Furthermore, the cleanroom's pass-through window lacked a pressure differential indicator, test water samples were unlabeled, and chemical solutions in the routine testing room lacked concentration labels. The company also failed to adhere to its own procedure for initial bacterial contamination testing, not selecting products of various specifications as required. As a result, Guanhao Biotech Co., Ltd. is mandated to rectify these issues promptly, assess all product safety risks, and initiate recalls for any potentially hazardous products. The Guangdong Provincial Food and Drug Administration will conduct follow-up inspections and report the rectification status to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/guanhao-biotech-co-ltd/66c94a35-4e66-43ff-b2cd-bb286dfcd025/