Argenta US Manufacturing LLC

FDA Regulatory Profile

Argenta US Manufacturing LLC has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Argenta US Manufacturing LLC" and its spelling variant "Argenta Us Manufacturing".

Latest inspection
Dec 15, 2023 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections11Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Argenta US Manufacturing LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Argenta US Manufacturing LLC: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 2 inspections220222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202220000
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202000000
201910000
201800000
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Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

11 inspections from Jun 17, 2009 to Dec 15, 2023.

DateSiteProductClassificationFEI
Dec 15, 2023Shawnee, KSVeterinaryVoluntary Action Indicated (VAI)1910953
Dec 14, 2022Shawnee, KSDrugsVoluntary Action Indicated (VAI)1910953
Oct 28, 2022Shawnee, KSVeterinaryVoluntary Action Indicated (VAI)1910953
Aug 1, 2019Shawnee, KSVeterinaryVoluntary Action Indicated (VAI)1910953
Aug 15, 2016Shawnee, KSDrugsNo Action Indicated (NAI)1910953
Jul 30, 2015Shawnee, KSDrugsVoluntary Action Indicated (VAI)1910953
Nov 1, 2013Shawnee, KSVeterinaryVoluntary Action Indicated (VAI)1910953
May 21, 2013Shawnee, KSDrugsVoluntary Action Indicated (VAI)1910953
Mar 8, 2012Shawnee, KSDrugsVoluntary Action Indicated (VAI)1910953
Jun 10, 2010Shawnee, KSVeterinaryVoluntary Action Indicated (VAI)1910953
Jun 17, 2009Shawnee, KSDrugsVoluntary Action Indicated (VAI)1910953
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1910953Shawnee, KS11Dec 15, 2023

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.