# China NMPA Inspection - Shandong Laibo Biotechnology Co., Ltd. - June 07, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shandong-laibo-biotechnology-co-ltd/a6897cb9-1559-44ca-85ee-0ff885272d68/
Source feed: China

> China NMPA unannounced inspection for Shandong Laibo Biotechnology Co., Ltd. published June 07, 2018. An unannounced inspection of Shandong Boke Biotechnology Industry Co., Ltd., producer of Biosafety Cabinets, was conducted from May 22-24, 2018. Based

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Shandong Boke Biotechnology Co., Ltd.
- Company Name: Shandong Laibo Biotechnology Co., Ltd.
- Publication Date: 2018-06-07
- Product Type: Device
- Summary: An unannounced inspection of Shandong Boke Biotechnology Industry Co., Ltd., producer of Biosafety Cabinets, was conducted from May 22-24, 2018. Based on the Good Manufacturing Practice for Medical Devices, the inspection revealed ten general deficiencies in the company's quality management system.

Key violations included the quality department's lack of involvement in handling returned substandard raw materials, disorganized critical material storage, and unapproved production deviations, such as replacing a fan for an urgent export order without established procedures. Production records lacked traceability, and control software updates were implemented without proper documentation, verification, or review. Supplier management was also deficient, with inadequate audits, missing quality scoring forms, and a failure to collect updated qualification certificates. Furthermore, incoming inspection records for critical components were incomplete, and the procedure for non-conforming products did not specify handling for production issues. The company also failed to analyze product quality data or customer feedback, leading to unaddressed recurring problems, such as those related to UV lamps.

As a result, Shandong Boke Biotechnology Industry Co., Ltd. is required to rectify all identified problems within a specified period, assess product safety risks, and recall any products with potential safety hazards. Follow-up inspections will be conducted, and the rectification status must be reported to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/shandong-laibo-biotechnology-co-ltd/4ff221c9-4dae-4022-94d1-eb12336d2735/