Tanita Corp. FDA Record

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

Tanita Corp. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Tanita Corp." is on file.

What these totals cover: FDA records filed under the name "Tanita Corp." and its spelling variants "Tanita", "Tanita Corporation".

Latest inspection
Jun 8, 2017 · NAI
Latest 510(k)
Apr 15, 2011

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Jun 8, 2017.

DateSiteProductClassificationFEI
Jun 8, 2017Itabashi, JapanDevicesNo Action Indicated (NAI)1000419277
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 1000419277Itabashi, Japan1Jun 8, 2017

Recent 510(k) clearances

1 510(k) clearance on Apr 15, 2011.

K-NumberDeviceDate
K100183MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZERApr 15, 2011

Tanita Corp. and the FDA: common questions

Has Tanita Corp. received an FDA warning letter?

No FDA warning letter addressed to the name "Tanita Corp." 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 Tanita Corp. received an FDA Form 483?

FDA has not published a Form 483 for "Tanita Corp." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Tanita Corp.?

The most recent FDA inspection on file ended Jun 8, 2017 at Itabashi, Japan and was classified NAI. FDA has 1 inspection of Tanita Corp. on file.

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