FDA action counts
| Total FDA actions | 1 |
|---|---|
| Warning letters | 0 |
| Recalls | 0 |
| Approval records | 0 |
| Form 483 inspection citations | 1 |
| Most recent action | January 17, 2025 |
Enforcement history
On 2025-01-17, Argus HQ recorded an FDA Form 483 inspection citation for Bio-Thera Solutions, Ltd., rated "high" severity in Argus HQ's classification: Bio-Thera Solutions, Ltd. -- FDA 483: 5 observations (2025-01-17). 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. Bio-Thera Solutions, 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
- Does Argus HQ track new FDA actions for Bio-Thera Solutions, 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 Bio-Thera Solutions, Ltd. is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Bio-Thera Solutions, 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 Bio-Thera Solutions, Ltd.?
- January 17, 2025. Argus HQ ingests new FDA enforcement records daily.
- Is this FDA enforcement data for Bio-Thera Solutions, Ltd. official?
- Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
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Related enforcement actions
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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). FDA Enforcement History: Bio-Thera Solutions, Ltd.. Digital Empire LLC. Retrieved from https://argushq.ai/company/bio-thera-solutions-ltd
"FDA Enforcement History: Bio-Thera Solutions, Ltd.." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/company/bio-thera-solutions-ltd.
Argus HQ Research. "FDA Enforcement History: Bio-Thera Solutions, Ltd.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/bio-thera-solutions-ltd.
@misc{argushq_argushq_ai_company_bio_thera_solutions_ltd_2025,
title = {FDA Enforcement History: Bio-Thera Solutions, Ltd.},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/bio-thera-solutions-ltd},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗