Showa Ika Kohgyo Co., Ltd. FDA Record

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

  • Latest inspection VAI · Feb 7, 2013
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 2 Latest Jul 2, 2008

Showa Ika Kohgyo Co., Ltd. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Showa Ika Kohgyo Co., Ltd." is on file.

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

Latest inspection
Feb 7, 2013 · VAI
Latest 510(k)
Jul 2, 2008

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 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 Feb 7, 2013.

DateSiteProductClassificationFEI
Feb 7, 2013Toyohashi, JapanDevicesVoluntary Action Indicated (VAI)3004589749
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 3004589749Toyohashi, Japan1Feb 7, 2013

Recent 510(k) clearances

2 510(k) clearances from Jul 3, 2006 to Jul 2, 2008.

K-NumberDeviceDate
K071074MYKRES SPINAL SYSTEMJul 2, 2008
K051704MYKRES SPINAL SYSTEMJul 3, 2006

Showa Ika Kohgyo Co., Ltd. and the FDA: common questions

Has Showa Ika Kohgyo Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Showa Ika Kohgyo 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 Showa Ika Kohgyo Co., Ltd. received an FDA Form 483?

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

When did the FDA last inspect Showa Ika Kohgyo Co., Ltd.?

The most recent FDA inspection on file ended Feb 7, 2013 at Toyohashi, Japan and was classified VAI. FDA has 1 inspection of Showa Ika Kohgyo Co., Ltd. on file.

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