# FDA 483 - Binex Co., Ltd - June 20, 2024

Source: https://www.keypedia.com/records/483/binex-co-ltd/edac097d-e10c-4c25-81ff-ad7cc928e710

> FDA 483 for Binex Co., Ltd on June 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Binex Co., Ltd
- Inspection Date: 2024-06-20
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Binex Ltd., a drug substance manufacturer in Incheon, Republic of Korea, was cited for significant deficiencies across its operations. The inspection revealed a lack of contamination prevention, inadequate data integrity controls for electronic systems, and widespread issues with laboratory controls. Furthermore, the Quality Unit's responsibilities and procedures were found to be insufficient, impacting record management and training.

## Related Officers

- [Aditi S. Thakur](https://www.keypedia.com/people/aditi-s-thakur/1c810eb2-86b0-4cae-b51d-43f3fb276ade)
- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/della-shin/8af7ca3c-d2c8-4712-9644-4de0bd4d638f)
- [Zachary Kraus](https://www.keypedia.com/people/zachary-kraus/9a85297e-4a21-49a6-a848-bc4a1e759f1a)

Company: https://www.keypedia.com/companies/binex-co-ltd/1fe6a991-8e83-46f9-b9e1-f6c2898254b2

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321