# FDA 483 - BrightGene BioMedical Technology Co., Ltd. - August 10, 2023

Source: https://www.keypedia.com/records/483/brightgene-biomedical-technology-co-ltd/bdd38797-112c-4ac5-88ee-c5572771eeb5

> FDA 483 for BrightGene BioMedical Technology Co., Ltd. on August 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BrightGene BioMedical Technology Co., Ltd.
- Inspection Date: 2023-08-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of BrightGene Bio-Medical Technology Co., Ltd. in Suzhou, China, revealed significant deficiencies within its quality control unit. The firm failed to adhere to established procedures, including a lack of raw data for vendor calibrations, incomplete data review forms for released batches, and inadequate investigations into system suitability failures and audit trail issues. These observations indicate a systemic breakdown in maintaining proper quality oversight and data integrity.

## Related Officers

- [Nivita Patel](https://www.keypedia.com/people/nivita-patel/40b1fa4b-5ff1-415e-9f2b-ca80a4981710)

Company: https://www.keypedia.com/companies/brightgene-biomedical-technology-co-ltd/3b5208d8-8184-49bf-8edf-2e9438a35972

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1