FDA action counts
| Total FDA actions | 1 |
|---|---|
| Warning letters | 0 |
| Recalls | 1 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | September 16, 2026 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Given Imaging 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.
Enforcement history
On 2026-09-16, Argus HQ recorded an FDA recall for Given Imaging Ltd., rated "critical" severity in Argus HQ's classification: Given Imaging Ltd. — Class I recall: Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF…. 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.
Frequently asked questions
- What is the most recent FDA action against Given Imaging Ltd.?
- The most recent FDA event Argus HQ has on file for Given Imaging Ltd. is dated 2026-09-16, with a severity rating of "critical" 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 Given Imaging 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 Given Imaging Ltd. is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Given Imaging Ltd.?
- 1 total: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Given Imaging Ltd.?
- September 16, 2026. Argus HQ ingests new FDA enforcement records daily.
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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
Verified from FDA.gov · Last updated: Sep 16, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Given Imaging Ltd. — FDA Compliance Timeline. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/given-imaging-ltd
"Given Imaging Ltd. — FDA Compliance Timeline." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/given-imaging-ltd.
Argus HQ Research. "Given Imaging Ltd. — FDA Compliance Timeline." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/company/given-imaging-ltd.
@misc{argushq_argushq_ai_company_given_imaging_ltd_2026,
title = {Given Imaging Ltd. — FDA Compliance Timeline},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/given-imaging-ltd},
note = {Accessed: September 23, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗