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Thermo Fisher Scientific Cork Limited FDA Record

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

Latest inspection VAI · Sep 7, 2022
Last warning letter 2014

Inspections 6

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Mar 18, 2014

510(k) clearances 0 None on file

Thermo Fisher Scientific Cork Limited has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Thermo Fisher Scientific Cork Limited, the most recent on Mar 18, 2014.

What these totals cover: FDA records filed under the name "Thermo Fisher Scientific Cork Limited".

Latest inspection: Sep 7, 2022 · VAI

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	6	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Thermo Fisher Scientific Cork Limited's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Thermo Fisher Scientific Cork Limited: 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	1	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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Thermo Fisher Scientific Cork Limited FDA Warning Letters

1 warning letter on Mar 18, 2014.

Issued	Subject	Issuing office	Close-out letter
Mar 18, 2014 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

6 inspections from Sep 10, 2009 to Sep 7, 2022.

Date	Site	Product	Classification	FEI
Sep 7, 2022	Carrigaline, Ireland	Drugs	Voluntary Action Indicated (VAI)	1000170338
Jul 26, 2019	Carrigaline, Ireland	Drugs	Voluntary Action Indicated (VAI)	1000170338
Jan 26, 2017	Carrigaline, Ireland	Drugs	Voluntary Action Indicated (VAI)	1000170338
May 1, 2015	Carrigaline, Ireland	Drugs	Voluntary Action Indicated (VAI)	1000170338
Oct 23, 2013	Carrigaline, Ireland	Drugs	Official Action Indicated (OAI)	1000170338
Sep 10, 2009	Carrigaline, Ireland	Drugs	No Action Indicated (NAI)	1000170338

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Thermo Fisher Scientific Cork Limited: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 18, 2014.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000170338	Carrigaline, Ireland	6	Sep 7, 2022

Thermo Fisher Scientific Cork Limited and the FDA: common questions

Has Thermo Fisher Scientific Cork Limited received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Thermo Fisher Scientific Cork Limited. The most recent is dated Mar 18, 2014.

Has Thermo Fisher Scientific Cork Limited received an FDA Form 483?

FDA has not published a Form 483 for "Thermo Fisher Scientific Cork Limited" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Thermo Fisher Scientific Cork Limited?

The most recent FDA inspection on file ended Sep 7, 2022 at Carrigaline, Ireland and was classified VAI. FDA has 6 inspections of Thermo Fisher Scientific Cork Limited on file, 1 of them classified OAI (official action indicated).

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