MARUTOMO CO., LTD.Second Factory FDA Record

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

  • Latest inspection NAI · Feb 28, 2023
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

MARUTOMO CO., LTD.Second Factory has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "MARUTOMO CO., LTD.Second Factory" is on file.

What these totals cover: FDA records filed under the name "MARUTOMO CO., LTD.Second Factory".

Latest inspection
Feb 28, 2023 · 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
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Feb 28, 2023.

DateSiteProductClassificationFEI
Feb 28, 2023Iyo, JapanFood/CosmeticsNo Action Indicated (NAI)3009172509
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 3009172509Iyo, Japan1Feb 28, 2023

MARUTOMO CO., LTD.Second Factory and the FDA: common questions

Has MARUTOMO CO., LTD.Second Factory received an FDA warning letter?

No FDA warning letter addressed to the name "MARUTOMO CO., LTD.Second Factory" 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 MARUTOMO CO., LTD.Second Factory received an FDA Form 483?

FDA has not published a Form 483 for "MARUTOMO CO., LTD.Second Factory" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect MARUTOMO CO., LTD.Second Factory?

The most recent FDA inspection on file ended Feb 28, 2023 at Iyo, Japan and was classified NAI. FDA has 1 inspection of MARUTOMO CO., LTD.Second Factory on file.

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