Catalent Australia Pty Ltd

FDA Regulatory Profile

Catalent Australia Pty Ltd has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 15, 2011 · NAI

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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
Inspections1Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

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Catalent Micron Technologies, Limited
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Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 15, 2011Braeside, AustraliaFood/CosmeticsNo Action Indicated (NAI)3004250913

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 3004250913Braeside, Australia1Nov 15, 2011

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