# China NMPA Inspection - Shandong Laibo Biotechnology Co., Ltd. - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shandong-laibo-biotechnology-co-ltd/50205a49-9f21-487e-9261-816cc7abd65b/
Source feed: China

> China NMPA unannounced inspection for Shandong Laibo Biotechnology Co., Ltd. published August 15, 2018. Shandong Laibo Biotechnology Co., Ltd. underwent an unannounced compliance inspection from July 24-25, 2018, by the regulatory authorities. This inspe

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Shandong Laibo Biotechnology Co., Ltd.
- Company Name: Shandong Laibo Biotechnology Co., Ltd.
- Publication Date: 2018-08-15
- Product Type: Device
- Summary: Shandong Laibo Biotechnology Co., Ltd. underwent an unannounced compliance inspection from July 24-25, 2018, by the regulatory authorities. This inspection focused on their Hepatitis C Virus Core Antigen Detection Kit and was based on Good Manufacturing Practice for Medical Devices and its Appendix for In Vitro Diagnostic Reagents. Seven general deficiencies were identified. Key violations included incomplete process validation for a pharmaceutical cabinet, specifically failing to perform full-load testing, and the absence of review records for critical document updates concerning material storage, production processes, and air conditioning unit operation. Discrepancies were also noted in employee training records. Furthermore, quality agreements with suppliers lacked essential content, such as technical and regulatory requirements. The company failed to retain the stipulated quantity of samples for quality control and lacked documented procedures for revalidating air purification systems after extended shutdowns. Finally, there were no established batch number management regulations for critical components like coating and enzyme-labeled antibodies. As a result, the company was ordered to rectify all identified issues promptly, assess product safety risks, and recall any potentially hazardous products. Follow-up inspections may be conducted, and the company must report its rectification progress to the National Medical Products Administration.

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