# FDA 483 - Fujian Genohope Biotech Ltd. - January 16, 2026

Source: https://www.globalkeysolutions.net/records/483/fujian-genohope-biotech-ltd/3e0cb306-9e79-42ae-9d06-be81f412b193

> FDA 483 for Fujian Genohope Biotech Ltd. on January 16, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fujian Genohope Biotech Ltd.
- Inspection Date: 2026-01-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Fujian Genohope Biotech Ltd., an API and sterile drug manufacturer, received a Form 483 for significant deficiencies in its cleaning validation program, including missing test results and visible residues on equipment. The firm also lacked appropriate controls over computer systems, specifically regarding the backup of quality manufacturing data without proper oversight or documentation. These observations indicate a need for improved quality control and data integrity practices.

## Related Documents

- [483 - 2023-06-02](https://www.globalkeysolutions.net/records/483/fujian-genohope-biotech-ltd/797d4ce0-d9f2-4b34-96f5-6f640abc3acc)

## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/fujian-genohope-biotech-ltd/2383a4ad-4fe8-4b52-b528-9b72885e00a9

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8