# FDA 483 - Samsung Bioepis Co., Ltd. - September 15, 2023

Source: https://www.keypedia.com/records/483/samsung-bioepis-co-ltd/3ea42fc3-70e9-45b2-a36d-d7f2c0e69b72

> FDA 483 for Samsung Bioepis Co., Ltd. on September 15, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samsung Bioepis Co., Ltd.
- Inspection Date: 2023-09-15
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: Samsung Bioepis Co., Ltd. in Incheon, Korea, was cited for significant deficiencies in its clinical study monitoring and post-marketing adverse event reporting. Observations included a failure to promptly report a subject's death to the FDA and extensive delays in resolving clinical study queries. Additionally, the firm failed to submit numerous 15-day alert reports for serious and unexpected adverse events within the required timeframe.

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## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.keypedia.com/companies/samsung-bioepis-co-ltd/6473332d-84de-441c-82fe-4034d7383d5e

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4