Skip to main content

fda_483 · inspection_citation · high

American Regent, Inc. -- FDA 483: 1 observation (2026-03-05)

Event date
2026-03-05 00:00:00Z
Observed
2026-08-17 05:01:23Z
Source ID
3003433784-2026-03-05-193863
Payload hash
60c36647267375f0b31ab9a7…

Summary

Observation 1: -- 1 of 4 -- -- 2 of 4 -- -- 3 of 4 -- The observations of objectionable conditions and practices listed on the front of this form are reported: 1. Pursuant to Section 704(b) of the Fed...

Entities

View source record ↗

Frequently asked questions

Has American Regent, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 14 total FDA actions tied to American Regent, Inc.: 0 warning letters, 13 recalls, 0 approval records, and 1 Form 483 inspection citation.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Form 483 Inspection Observation, tagged high severity by Argus HQ. FDA published the underlying record on 2026-03-05; Argus observed and indexed it on 2026-08-17.
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). American Regent, Inc. -- FDA 483: 1 observation (2026-03-05). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-483-american-regent-inc-2026-03-05-3003433784
MLA
"American Regent, Inc. -- FDA 483: 1 observation (2026-03-05)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-483-american-regent-inc-2026-03-05-3003433784.
Chicago
Argus HQ Research. "American Regent, Inc. -- FDA 483: 1 observation (2026-03-05)." Digital Empire Holdings LLC. Accessed September 8, 2026. https://argushq.ai/events/fda-483-american-regent-inc-2026-03-05-3003433784.
BibTeX
@misc{argushq_argushq_ai_events_fda_483_american_regent_inc_2026_03_05_3003433784_2026,
  title = {American Regent, Inc. -- FDA 483: 1 observation (2026-03-05)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-483-american-regent-inc-2026-03-05-3003433784},
  note = {Accessed: September 8, 2026}
}

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

American Regent, Inc. -- FDA 483: 1 observation (2026-03-05) · Argus HQ