Fujifilm Diosynth Biotechnologies Texas, LLC — FDA Enforcement History

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Fujifilm Diosynth Biotechnologies Texas, LLC 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 2025-03-11, Argus HQ recorded an FDA Form 483 inspection citation for Fujifilm Diosynth Biotechnologies Texas, LLC, rated "high" severity in Argus HQ's classification: Fujifilm Diosynth Biotechnologies Texas, LLC -- FDA 483: 8 observations (2025-03-11). 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

Is this FDA enforcement data for Fujifilm Diosynth Biotechnologies Texas, LLC 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.

How many FDA actions has Fujifilm Diosynth Biotechnologies Texas, LLC had?

Argus HQ has recorded 1 FDA events for Fujifilm Diosynth Biotechnologies Texas, LLC: 0 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 Fujifilm Diosynth Biotechnologies Texas, LLC?

The most recent FDA event Argus HQ has on file for Fujifilm Diosynth Biotechnologies Texas, LLC is dated 2025-03-11, 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 Fujifilm Diosynth Biotechnologies Texas, LLC 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 Fujifilm Diosynth Biotechnologies Texas, LLC is observed, this page's event count and history update automatically.

Related enforcement actions

• Fujifilm Diosynth Biotechnologies Texas, LLC -- FDA 483: 8 observations (2025-03-11) →

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