# FDA 483 - BrightGene Fine Chemical Co., Ltd (Tongyuan Road) - January 20, 2024

Source: https://www.keypedia.com/records/483/brightgene-fine-chemical-co-ltd-tongyuan-road/1a955097-0506-44e5-9b78-b9dd4a49ec6e

> FDA 483 for BrightGene Fine Chemical Co., Ltd (Tongyuan Road) on January 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BrightGene Fine Chemical Co., Ltd (Tongyuan Road)
- Inspection Date: 2024-01-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: BrightGene Fine Chemical Co. Ltd. in Taizhou, Jiangsu, China, received a Form FDA 483 with six observations following an inspection from January 15-20, 2024. The inspection revealed significant deficiencies across manufacturing process validation, quality unit oversight, laboratory controls, equipment maintenance, and supplier qualification. These issues indicate a systemic failure to adhere to cGMP requirements for intermediates and active pharmaceutical ingredients, with some observations being repeats from previous inspections.

## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.keypedia.com/companies/brightgene-fine-chemical-co-ltd-tongyuan-road/6829d08d-3634-4dd8-9018-1479d16cb615

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