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Heliora Laboratories Pty Ltd.

FDA Regulatory Profile

Heliora Laboratories Pty Ltd. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Jun 21, 2024 · OAI

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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) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 21, 2024Osborne Park, AustraliaDrugsOfficial Action Indicated (OAI)3006210769
Jun 17, 2022Osborne Park, AustraliaDrugsOfficial Action Indicated (OAI)3006210769
May 31, 2019Osborne Park, AustraliaDrugsOfficial Action Indicated (OAI)3006210769

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 3006210769Osborne Park, Australia3Jun 21, 2024

FDA data resources

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