Intronix Technologies Corp. FDA Record

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

  • Latest inspection VAI · Feb 26, 2015
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 1 Latest Dec 30, 2011

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

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

Latest inspection
Feb 26, 2015 · VAI
Latest 510(k)
Dec 30, 2011

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) clearances1Nov 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 26, 2015.

DateSiteProductClassificationFEI
Feb 26, 2015Bolton, CanadaDevicesVoluntary Action Indicated (VAI)3000155035
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 3000155035Bolton, Canada1Feb 26, 2015

Recent 510(k) clearances

1 510(k) clearance on Dec 30, 2011.

K-NumberDeviceDate
K111985MYOGUIDE SYSTEM MODEL 8008Dec 30, 2011

Intronix Technologies Corp. and the FDA: common questions

Has Intronix Technologies Corp. received an FDA warning letter?

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

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

When did the FDA last inspect Intronix Technologies Corp.?

The most recent FDA inspection on file ended Feb 26, 2015 at Bolton, Canada and was classified VAI. FDA has 1 inspection of Intronix Technologies Corp. on file.

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