Kuki Sangyo Co., Ltd. FDA Record

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

  • Latest inspection NAI · Feb 26, 2018
  • No warning letters matched by name
Inspections 2 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Kuki Sangyo Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kuki Sangyo Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Kuki Sangyo Co., Ltd." and its spelling variant "Kuki Sangyo Co".

Latest inspection
Feb 26, 2018 · 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
Inspections2Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

2 inspections from Nov 22, 2012 to Feb 26, 2018.

DateSiteProductClassificationFEI
Feb 26, 2018Yokkaichi, JapanFood/CosmeticsNo Action Indicated (NAI)1000272783
Nov 22, 2012Yokkaichi, JapanFood/CosmeticsVoluntary Action Indicated (VAI)1000272783
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 1000272783Yokkaichi, Japan2Feb 26, 2018

Kuki Sangyo Co., Ltd. and the FDA: common questions

Has Kuki Sangyo Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Kuki Sangyo Co., Ltd." 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 Kuki Sangyo Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Kuki Sangyo Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Kuki Sangyo Co., Ltd.?

The most recent FDA inspection on file ended Feb 26, 2018 at Yokkaichi, Japan and was classified NAI. FDA has 2 inspections of Kuki Sangyo Co., Ltd. on file.

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