Is this FDA enforcement data for QILU PHARM HAINAN 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 QILU PHARM HAINAN had?

Argus HQ has recorded 1 FDA events for QILU PHARM HAINAN: 0 warning letters, 0 recalls, 1 approvals, and 0 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 QILU PHARM HAINAN?

The most recent FDA event Argus HQ has on file for QILU PHARM HAINAN is dated 2026-07-28, with a severity rating of "info" 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 QILU PHARM HAINAN 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 QILU PHARM HAINAN is observed, this page's event count and history update automatically.

Regulatory Record: QILU PHARM HAINAN

FDA action counts

Total FDA actions	1
Warning letters	0
Recalls	0
Approval records	1
Form 483 inspection citations	0
Most recent action	July 28, 2026

The short version: Argus HQ has recorded 1 FDA events for QILU PHARM HAINAN: 0 warning letters, 0 recalls, 1 approvals, and 0 inspection 483 observations. These events span from 2026-07-28 to 2026-07-28. The most severe rating Argus HQ has assigned across this history is "info". 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. QILU PHARM HAINAN 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 2026-07-28, Argus HQ recorded an FDA approval for QILU PHARM HAINAN, rated "info" severity in Argus HQ's classification: QILU PHARM HAINAN — ANDA approval: SUGAMMADEX SODIUM (unspecified). 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 QILU PHARM HAINAN 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 QILU PHARM HAINAN had?: Argus HQ has recorded 1 FDA events for QILU PHARM HAINAN: 0 warning letters, 0 recalls, 1 approvals, and 0 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 QILU PHARM HAINAN?: The most recent FDA event Argus HQ has on file for QILU PHARM HAINAN is dated 2026-07-28, with a severity rating of "info" 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 QILU PHARM HAINAN 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 QILU PHARM HAINAN is observed, this page's event count and history update automatically.

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QILU PHARM HAINAN — ANDA approval: SUGAMMADEX SODIUM (unspecified) →

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Jul 28, 2026

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Regulatory Record: QILU PHARM HAINAN. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/qilu-pharm-hainan

MLA

"Regulatory Record: QILU PHARM HAINAN." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/qilu-pharm-hainan.

Chicago

Argus HQ Research. "Regulatory Record: QILU PHARM HAINAN." Digital Empire Holdings LLC. Accessed August 1, 2026. https://argushq.ai/company/qilu-pharm-hainan.

BibTeX

@misc{argushq_argushq_ai_company_qilu_pharm_hainan_2026,
  title = {Regulatory Record: QILU PHARM HAINAN},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/qilu-pharm-hainan},
  note = {Accessed: August 1, 2026}
}

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