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

Source: https://www.keypedia.com/records/483/samsung-bioepis-co-ltd/315a6a1d-3e37-4577-b209-cb07acedaefb

> FDA 483 for Samsung Bioepis Co., Ltd. on September 15, 2023. Product: Drugs. 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: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Samsung Bioepis Co., Ltd., located at 76 Songdogyoyuk-Ro, Yeonsu, INCHEON, 21987 Korea (the Republic of), was conducted from September 4 to September 15, 2023. The facility operates as a Sponsor and PADE (Pharmacovigilance and Drug Evaluation) establishment. The inspection identified two observations.

Observation 1 noted a failure to ensure proper study monitoring, adherence to the protocol, and prompt reporting of significant new adverse effects or risks to the FDA and investigators. Specifically, a subject's death was not promptly reported to the FDA; the sponsor was not informed until March 9, 2020, despite the clinical investigator identifying the fatal event earlier. Additionally, 187 clinical monitoring queries took 20 days or more to resolve, with 33 taking 50 days or longer, and one query remaining unresolved for 445 days, contrary to the Monitoring Plan's stated query resolution timelines.

Observation 2 cited a failure to submit required post-marketing 15-day alert and follow-up reports. Review of expedited 15-day alert reports revealed 16 Serious and Unexpected Adverse Events cases were incorrectly processed, resulting in reports exceeding the 15-day timeframe. Fifteen of these 16 cases were submitted more than 40 days late, with delays ranging from

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## Related Officers

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

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