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South Pacific Sera Limited

FDA Regulatory Profile

South Pacific Sera Limited has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "South Pacific Sera Limited".

Latest inspection
Dec 1, 2016 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

3 inspections from Oct 28, 2009 to Dec 1, 2016.

DateSiteProductClassificationFEI
Dec 1, 2016Timaru, New ZealandDrugsVoluntary Action Indicated (VAI)3001765316
Nov 13, 2014Timaru, New ZealandDrugsVoluntary Action Indicated (VAI)3001765316
Oct 28, 2009Timaru, New ZealandDrugsNo Action Indicated (NAI)3001765316
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 3001765316Timaru, New Zealand3Dec 1, 2016

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FDA data resources

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