Maruzen Of America, Inc FDA Record

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

  • Latest inspection NAI · Dec 23, 2025
  • No warning letters matched by name
Inspections 7 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Maruzen Of America, Inc has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Maruzen Of America, Inc" is on file.

What these totals cover: FDA records filed under the name "Maruzen Of America, Inc" and its spelling variant "Maruzen Of America".

Latest inspection
Dec 23, 2025 · 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
Inspections7Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Maruzen Of America, Inc's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Maruzen Of America, Inc: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202520000
202400000
202300000
202200000
202100000
202000000
201910000
201810000
201700000

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

7 inspections from Nov 17, 2009 to Dec 23, 2025.

DateSiteProductClassificationFEI
Dec 23, 2025Carson, CAFood/CosmeticsNo Action Indicated (NAI)3004331497
Jul 9, 2025Compton, CAFood/CosmeticsNo Action Indicated (NAI)3000210700
Apr 5, 2019Carson, CAFood/CosmeticsNo Action Indicated (NAI)3004331497
May 9, 2018Compton, CAFood/CosmeticsNo Action Indicated (NAI)3000210700
Jan 16, 2013Compton, CAFood/CosmeticsNo Action Indicated (NAI)3000210700
Mar 6, 2012Carson, CAFood/CosmeticsVoluntary Action Indicated (VAI)3004331497
Nov 17, 2009Carson, CAFood/CosmeticsNo Action Indicated (NAI)3004331497
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3004331497Carson, CA4Dec 23, 2025
FEI 3000210700Compton, CA3Jul 9, 2025

Maruzen Of America, Inc and the FDA: common questions

Has Maruzen Of America, Inc received an FDA warning letter?

No FDA warning letter addressed to the name "Maruzen Of 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 Maruzen Of America, Inc received an FDA Form 483?

FDA has not published a Form 483 for "Maruzen Of America, Inc" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Maruzen Of America, Inc?

The most recent FDA inspection on file ended Dec 23, 2025 at Carson, CA and was classified NAI. FDA has 7 inspections of Maruzen Of America, Inc on file.

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