# FDA 483 - Eone Laboratories - April 09, 2019

Source: https://www.keypedia.com/records/483/eone-laboratories/ca3288da-c553-4848-976e-34d82f6c649c

> FDA 483 for Eone Laboratories on April 09, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eone Laboratories
- Inspection Date: 2019-04-09
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Komg Laboratories, an HCT/P Microbiological Testing Laboratory in Incheon, Korea, was inspected by the FDA. The inspection revealed significant deficiencies in record-keeping practices, specifically concerning microbiological testing and the use and maintenance of laboratory equipment. These issues indicate a lack of detailed documentation necessary to ensure product quality and process control.

## Related Documents

- [483 - 2023-08-30](https://www.keypedia.com/records/483/eone-laboratories/05e8f8e1-1e58-4338-b85e-ad8e49131cdc)

## Related Officers

- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd