Isomers Laboratories, Inc.

FDA Regulatory Profile

Isomers Laboratories, Inc. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
May 11, 2018 · OAI
Latest 510(k)
Sep 4, 2008

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 11, 2018North York, CanadaDrugsOfficial Action Indicated (OAI)3001576415
May 29, 2014North York, CanadaDrugsVoluntary Action Indicated (VAI)3001576415
Sep 29, 2011North York, CanadaDrugsVoluntary Action Indicated (VAI)3001576415

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3001576415North York, Canada3May 11, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K070250NUTRITONE FACIAL BEAUTY SYSTEMSep 4, 2008

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