Has Fresenius Kabi USA, LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 23 total FDA actions tied to Fresenius Kabi USA, LLC: 0 warning letters, 22 recalls, 1 approval record, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Drug Approval, tagged info severity by Argus HQ. FDA published the underlying record on 2026-07-29; Argus observed and indexed it on 2026-08-01.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_approval · nda · info

FRESENIUS KABI USA LLC — NDA approval: Unspecified (unspecified)

Name: FDA Drug Approval Record — Fresenius Kabi USA, LLC
Creator: Argus HQ
Published: 2026-07-29
License: https://argushq.ai/methodology

Event date: 2026-07-29 00:00:00Z
Observed: 2026-08-01 04:30:21Z
Source ID: NDA220381-1
Payload hash: d49c5cb0cad87c62acf7c1b4…

Summary

FRESENIUS KABI USA LLC received NDA approval for Unspecified (unspecified) on 2026-07-29. Dosage form: unspecified dosage form. Application #: NDA220381.

Entities

Fresenius Kabi USA, LLC

View source record ↗

Frequently asked questions

Has Fresenius Kabi USA, LLC had other FDA enforcement actions?: Yes. Argus HQ has recorded 23 total FDA actions tied to Fresenius Kabi USA, LLC: 0 warning letters, 22 recalls, 1 approval record, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Drug Approval, tagged info severity by Argus HQ. FDA published the underlying record on 2026-07-29; Argus observed and indexed it on 2026-08-01.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

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). FRESENIUS KABI USA LLC — NDA approval: Unspecified (unspecified). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-approval-fresenius-kabi-usa-llc-nda220381-1

MLA

"FRESENIUS KABI USA LLC — NDA approval: Unspecified (unspecified)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-approval-fresenius-kabi-usa-llc-nda220381-1.

Chicago

Argus HQ Research. "FRESENIUS KABI USA LLC — NDA approval: Unspecified (unspecified)." Digital Empire Holdings LLC. Accessed August 1, 2026. https://argushq.ai/events/fda-approval-fresenius-kabi-usa-llc-nda220381-1.

BibTeX

@misc{argushq_argushq_ai_events_fda_approval_fresenius_kabi_usa_llc_nda220381_1_2026,
  title = {FRESENIUS KABI USA LLC — NDA approval: Unspecified (unspecified)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-approval-fresenius-kabi-usa-llc-nda220381-1},
  note = {Accessed: August 1, 2026}
}

Informational only. Not legal, financial, or medical advice.