# FDA 483 - Fujian Genohope Biotech Ltd. - June 02, 2023

Source: https://www.globalkeysolutions.net/records/483/fujian-genohope-biotech-ltd/797d4ce0-d9f2-4b34-96f5-6f640abc3acc

> FDA 483 for Fujian Genohope Biotech Ltd. on June 02, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fujian Genohope Biotech Ltd.
- Inspection Date: 2023-06-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Fujian Genhope Biotech Ltd, a sterile manufacturer in Putian, China, was cited for significant deficiencies across its manufacturing operations. Observations included failure to follow written procedures for component handling, inadequate equipment qualification and use, poor electronic data integrity practices, and insufficient production and process controls. These issues indicate a systemic lack of adherence to good manufacturing practices, potentially impacting product quality and safety.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kevin-t-nguyen/5ae9d562-7e4f-4305-895a-4b39c35acd16)
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Company: https://www.globalkeysolutions.net/companies/fujian-genohope-biotech-ltd/2383a4ad-4fe8-4b52-b528-9b72885e00a9

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