Ajinomoto Health & Nutrition North America, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection NAI · May 8, 2026
  • No warning letters matched by name
Inspections 18 1 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Ajinomoto Health & Nutrition North America, Inc. has 0 FDA recalls, 18 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ajinomoto Health & Nutrition North America, Inc." is on file.

What these totals cover: FDA records filed under the name "Ajinomoto Health & Nutrition North America, Inc." and its spelling variant "Ajinomoto Health And Nutrition North America".

Latest inspection
May 8, 2026 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections18Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Ajinomoto Health & Nutrition North America, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Ajinomoto Health & Nutrition North America, Inc.: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202630000
202520000
202400000
202321000
202200000
202110000
202000000
201920000
201800000
201710000

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.

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Recent FDA inspections

18 inspections from Apr 13, 2010 to May 8, 2026.

DateSiteProductClassificationFEI
May 8, 2026Itasca, ILFood/CosmeticsNo Action Indicated (NAI)1000080054
Apr 1, 2026Raleigh, NCFood/CosmeticsNo Action Indicated (NAI)1033510
Jan 28, 2026Raleigh, NCFood/CosmeticsNo Action Indicated (NAI)3013972253
Sep 12, 2025Eddyville, IADrugsVoluntary Action Indicated (VAI)3003918018
Aug 6, 2025Raleigh, NCDrugsNo Action Indicated (NAI)1033510
Nov 29, 2023Raleigh, NCFood/CosmeticsNo Action Indicated (NAI)3013972253
Nov 14, 2023Eddyville, IADrugsOfficial Action Indicated (OAI)3003918018
Jun 15, 2021Itasca, ILFood/CosmeticsNo Action Indicated (NAI)1000080054
Nov 13, 2019Akron, OHFood/CosmeticsNo Action Indicated (NAI)3004280014
Oct 29, 2019Akron, OHFood/CosmeticsNo Action Indicated (NAI)3010704558
Dec 8, 2017Raleigh, NCDrugsVoluntary Action Indicated (VAI)1033510
Nov 18, 2016Akron, OHFood/CosmeticsVoluntary Action Indicated (VAI)3004280014
Oct 29, 2014Eddyville, IAFood/CosmeticsNo Action Indicated (NAI)1000147966
May 21, 2014Raleigh, NCDrugsVoluntary Action Indicated (VAI)1033510
Apr 9, 2012Eddyville, IAFood/CosmeticsNo Action Indicated (NAI)1000147966
Mar 25, 2011Akron, OHFood/CosmeticsVoluntary Action Indicated (VAI)3004280014
Jun 24, 2010Akron, OHFood/CosmeticsNo Action Indicated (NAI)3004280014
Apr 13, 2010Raleigh, NCDrugsVoluntary Action Indicated (VAI)1033510
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

7 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1000080054Itasca, IL2May 8, 2026
FEI 1033510Raleigh, NC5Apr 1, 2026
FEI 3013972253Raleigh, NC2Jan 28, 2026
FEI 3003918018Eddyville, IA2Sep 12, 2025
FEI 3004280014Akron, OH4Nov 13, 2019
FEI 3010704558Akron, OH1Oct 29, 2019
FEI 1000147966Eddyville, IA2Oct 29, 2014

Ajinomoto Health & Nutrition North America, Inc. and the FDA: common questions

Has Ajinomoto Health & Nutrition North America, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Ajinomoto Health & Nutrition North America, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Ajinomoto Health & Nutrition North America, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Ajinomoto Health & Nutrition North America, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Ajinomoto Health & Nutrition North America, Inc.?

The most recent FDA inspection on file ended May 8, 2026 at Itasca, IL and was classified NAI. FDA has 18 inspections of Ajinomoto Health & Nutrition North America, Inc. on file, 1 of them classified OAI (official action indicated).

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