How many FDA actions has Genzyme Ireland Limited had?

Argus HQ has recorded 2 FDA events for Genzyme Ireland Limited: 1 warning letters, 0 recalls, 0 approvals, and 1 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Genzyme Ireland Limited?

The most recent FDA event Argus HQ has on file for Genzyme Ireland Limited is dated 2026-06-22, 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 Genzyme Ireland Limited 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 Genzyme Ireland Limited is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Genzyme Ireland Limited?

2 total: 1 warning letter, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Genzyme Ireland Limited's Complete FDA Record

FDA action counts

Total FDA actions	2
Warning letters	1
Recalls	0
Approval records	0
Form 483 inspection citations	1
Most recent action	June 22, 2026

In short: Argus HQ has recorded 2 FDA events for Genzyme Ireland Limited: 1 warning letters, 0 recalls, 0 approvals, and 1 inspection 483 observations. These events span from 2025-01-17 to 2026-06-22. The most severe rating Argus HQ has assigned across this history is "critical". 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.

Enforcement history

On 2026-06-22, Argus HQ recorded an FDA Warning Letter for Genzyme Ireland Limited, rated "critical" severity in Argus HQ's classification: Genzyme Ireland Limited — CGMP/Deviations/Biologics License Application (BLA) (2026-06-22). On 2025-01-17, Argus HQ recorded an FDA Form 483 inspection citation for Genzyme Ireland Limited, rated "high" severity in Argus HQ's classification: Genzyme Ireland Limited -- FDA 483: 1 observation (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. Genzyme Ireland Limited has 2 FDA events 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

How many FDA actions has Genzyme Ireland Limited had?: Argus HQ has recorded 2 FDA events for Genzyme Ireland Limited: 1 warning letters, 0 recalls, 0 approvals, and 1 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against Genzyme Ireland Limited?: The most recent FDA event Argus HQ has on file for Genzyme Ireland Limited is dated 2026-06-22, 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 Genzyme Ireland Limited 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 Genzyme Ireland Limited is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for Genzyme Ireland Limited?: 2 total: 1 warning letter, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

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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.

APA

Argus HQ Research (2026). Genzyme Ireland Limited's Complete FDA Record. Digital Empire LLC. Retrieved from https://argushq.ai/company/genzyme-ireland-limited

MLA

"Genzyme Ireland Limited's Complete FDA Record." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/genzyme-ireland-limited.

Chicago

Argus HQ Research. "Genzyme Ireland Limited's Complete FDA Record." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/genzyme-ireland-limited.

BibTeX

@misc{argushq_argushq_ai_company_genzyme_ireland_limited_2026,
  title = {Genzyme Ireland Limited's Complete FDA Record},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/genzyme-ireland-limited},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗