# FDA 483 - Akeso Biopharma Co., Ltd. - March 04, 2025

Source: https://www.globalkeysolutions.net/records/483/akeso-biopharma-co-ltd/336122fa-825e-4aa9-b501-95130811edba

> FDA 483 for Akeso Biopharma Co., Ltd. on March 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Akeso Biopharma Co., Ltd.
- Inspection Date: 2025-03-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Akeso Biopharma, Co., Ltd. in Zhongshan, China, was cited for significant deficiencies during an FDA inspection of its drug substance and drug product manufacturing. The firm's visual inspection program, laboratory controls, and quality unit oversight were found to be inadequate. Additionally, issues were identified with procedures for preventing microbiological contamination, the design and maintenance of facilities and equipment, and non-conformance to submitted information regarding reference standard testing.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/akeso-biopharma-co-ltd/dad1d4e2-44eb-40f3-884d-72e0320acf54)

## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.globalkeysolutions.net/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [issuing_officer](https://www.globalkeysolutions.net/people/charles-y-kuo/36d44416-c980-4b33-b62e-ea0761a46a46)
- [Yun Wu](https://www.globalkeysolutions.net/people/yun-wu/ae378596-ea82-4254-b169-b592878202eb)
- [Khalid M. Khan](https://www.globalkeysolutions.net/people/khalid-m-khan/fb4bde8b-b17c-4686-b5af-e602c8a46e18)
- [investigator](https://www.globalkeysolutions.net/people/thuy-thanh-nguyen/8e2e9be6-8d27-45d9-a3b0-cf3e9a0eb3c4)

Company: https://www.globalkeysolutions.net/companies/akeso-biopharma-co-ltd/5e7be927-b0ec-4dd3-83d6-9a9bd61cf75b

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