# FDA 483 - Eone Laboratories - August 30, 2023

Source: https://www.keypedia.com/records/483/eone-laboratories/05e8f8e1-1e58-4338-b85e-ad8e49131cdc

> FDA 483 for Eone Laboratories on August 30, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eone Laboratories
- Inspection Date: 2023-08-30
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of Eone Laboratories, a testing laboratory in Incheon, Korea, revealed a significant repeat observation regarding inadequate record-keeping for microbiology testing of HCT/P products. The firm failed to maintain detailed records providing a complete history of work performed, specifically concerning microbiology worksheets, sample readings, and secondary reviews. This repeated finding indicates a persistent issue with documentation practices at the facility.

## Related Documents

- [483 - 2019-04-09](https://www.keypedia.com/records/483/eone-laboratories/ca3288da-c553-4848-976e-34d82f6c649c)

## Related Officers

- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/eone-laboratories/3f316442-252e-42df-b9bd-548bd062a6f4

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