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Eurofins Biopharma Product Testing Australia Pty. Ltd. FDA Record

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

Latest inspection NAI · Nov 4, 2022
No warning letters matched by name

Inspections 4

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Eurofins Biopharma Product Testing Australia Pty. Ltd. has 0 FDA recalls, 4 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 Pty". Records filed under related names are not included; see Related names.

Latest inspection: Nov 4, 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	4	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).

Eurofins Biopharma Product Testing Australia Pty. Ltd.: FDA inspections per year

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	Same company group	0	0	3	0	—

Recent FDA inspections

4 inspections from Mar 3, 2010 to Nov 4, 2022.

Date	Site	Product	Classification	FEI
Nov 4, 2022	Girraween, Australia	Veterinary	No Action Indicated (NAI)	3006635869
Mar 24, 2017	Girraween, Australia	Veterinary	Voluntary Action Indicated (VAI)	3006635869
Jul 24, 2013	Girraween, Australia	Drugs	Voluntary Action Indicated (VAI)	3006635869
Mar 3, 2010	Girraween, Australia	Drugs	Voluntary Action Indicated (VAI)	3006635869

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 3006635869	Girraween, Australia	4	Nov 4, 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 Nov 4, 2022 at Girraween, Australia and was classified NAI. FDA has 4 inspections of Eurofins Biopharma Product Testing Australia Pty. Ltd. on file.

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