FDA action counts
| Total FDA actions | 1 |
|---|---|
| Warning letters | 0 |
| Recalls | 0 |
| Approval records | 0 |
| Form 483 inspection citations | 1 |
| Most recent action | November 22, 2024 |
Enforcement history
On 2024-11-22, Argus HQ recorded an FDA Form 483 inspection citation for Samsung Bioepis Co. Ltd., rated "high" severity in Argus HQ's classification: Samsung Bioepis Co. Ltd. -- FDA 483: 2 observations (2024-11-22). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Samsung Bioepis Co. Ltd. has 1 FDA event on file. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Frequently asked questions
- What is the most recent FDA action against Samsung Bioepis Co. Ltd.?
- The most recent FDA event Argus HQ has on file for Samsung Bioepis Co. Ltd. is dated 2024-11-22, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
- Does Argus HQ track new FDA actions for Samsung Bioepis Co. Ltd. automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Samsung Bioepis Co. Ltd. is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Samsung Bioepis Co. Ltd.?
- 1 total: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
- What is the most recent FDA action on file for Samsung Bioepis Co. Ltd.?
- November 22, 2024. Argus HQ ingests new FDA enforcement records daily.
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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Nov 22, 2024Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2024). Regulatory Record: Samsung Bioepis Co. Ltd.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/samsung-bioepis-co-ltd
"Regulatory Record: Samsung Bioepis Co. Ltd.." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/company/samsung-bioepis-co-ltd.
Argus HQ Research. "Regulatory Record: Samsung Bioepis Co. Ltd.." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/company/samsung-bioepis-co-ltd.
@misc{argushq_argushq_ai_company_samsung_bioepis_co_ltd_2024,
title = {Regulatory Record: Samsung Bioepis Co. Ltd.},
author = {{Argus HQ Research}},
year = {2024},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/samsung-bioepis-co-ltd},
note = {Accessed: August 29, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗