# China NMPA Inspection - BGI Genomics (Shenzhen) Co., Ltd. - April 27, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/bgi-genomics-shenzhen-co-ltd/4883a353-e8b2-4398-ac62-fa4ce7676316/
Source feed: China

> China NMPA unannounced inspection for BGI Genomics (Shenzhen) Co., Ltd. published April 27, 2017. An unannounced inspection conducted by a regulatory authority, specifically documented in a report published on April 27, 2017, brought to light signi

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## Details

- Record Type: CHINA_INSPECTION
- Title: Flight inspection of BGI Genomics (Shenzhen) Co., Ltd.
- Company Name: BGI Genomics (Shenzhen) Co., Ltd.
- Publication Date: 2017-04-27
- Product Type: Device
- Summary: An unannounced inspection conducted by a regulatory authority, specifically documented in a report published on April 27, 2017, brought to light significant compliance issues at BGI Genomics (Shenzhen) Co., Ltd. The inspection revealed that the company's operational practices were not in alignment with the stringent requirements of the Good Manufacturing Practice for Medical Devices. Key issues revolved around identified deficiencies within its overarching quality management system, indicating a shortfall in maintaining the necessary standards for the production of medical devices. Following these critical findings, the Guangdong Provincial Food and Drug Administration, acting under its regulatory authority, issued a formal order. This directive mandates that BGI Genomics (Shenzhen) Co., Ltd. must undertake comprehensive corrective actions to rectify all identified deficiencies within a specified period. This regulatory action highlights the critical importance of rigorous adherence to established manufacturing and quality control standards, ensuring that medical devices meet all safety and efficacy benchmarks for public health protection.

Company: https://www.globalkeysolutions.net/companies/bgi-genomics-shenzhen-co-ltd/6057a983-7791-48e1-b760-bbcaf862d2f7/