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Eurofins BioPharma Product Testing Australia Pty Ltd. FDA Record

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

Eurofins BioPharma Product Testing Australia Pty Ltd. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Eurofins BioPharma Product Testing Australia Pty Ltd." is on file.

What these totals cover: FDA records filed under the name "Eurofins BioPharma Product Testing Australia Pty Ltd." and its spelling variant "Eurofins Biopharma Product Testing Australia". Records filed under related names are not included; see Related names.

Latest inspection: Jul 27, 2022 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Eurofins BioPharma Product Testing Australia Pty Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Eurofins BioPharma Product Testing Australia Pty Ltd. above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Eurofins Biopharma Product Testing Australia Pty	Same company group	0	0	4	0	—

Recent FDA inspections

3 inspections from Jun 27, 2014 to Jul 27, 2022.

Date	Site	Product	Classification	FEI
Jul 27, 2022	Dandenong South, Australia	Drugs	No Action Indicated (NAI)	3006948403
Mar 24, 2017	Dandenong South, Australia	Drugs	Voluntary Action Indicated (VAI)	3006948403
Jun 27, 2014	Dandenong South, Australia	Drugs	Official Action Indicated (OAI)	3006948403

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.

Facility	Location	Inspections	Latest
FEI 3006948403	Dandenong South, Australia	3	Jul 27, 2022

Eurofins BioPharma Product Testing Australia Pty Ltd. and the FDA: common questions

Has Eurofins BioPharma Product Testing Australia Pty Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Eurofins BioPharma Product Testing Australia Pty Ltd." 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 Eurofins BioPharma Product Testing Australia Pty Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Eurofins BioPharma Product Testing Australia Pty Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Eurofins BioPharma Product Testing Australia Pty Ltd.?

The most recent FDA inspection on file ended Jul 27, 2022 at Dandenong South, Australia and was classified NAI. FDA has 3 inspections of Eurofins BioPharma Product Testing Australia Pty Ltd. on file, 1 of them classified OAI (official action indicated).

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