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Thermo Electron LED GmbH FDA Record

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

Thermo Electron LED GmbH has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Thermo Electron LED GmbH" is on file. FDA has published 1 Form 483 for Thermo Electron LED GmbH.

What these totals cover: FDA records filed under the name "Thermo Electron LED GmbH" and its spelling variant "Thermo Electron Led".

Latest inspection: Mar 20, 2025 · 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

Thermo Electron LED GmbH'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	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	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 Electron LED GmbH Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Mar 20, 2025 · Document on fda.gov	483	3005737891

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

3 inspections from Jan 22, 2015 to Mar 20, 2025.

Date	Site	Product	Classification	FEI
Mar 20, 2025	Langenselbold, Germany	Devices	No Action Indicated (NAI)	3005737891
Apr 26, 2018	Langenselbold, Germany	Devices	Voluntary Action Indicated (VAI)	3005737891
Jan 22, 2015	Langenselbold, Germany	Devices	Voluntary Action Indicated (VAI)	3005737891

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 3005737891	Langenselbold, Germany	3	Mar 20, 2025

Thermo Electron LED GmbH and the FDA: common questions

Has Thermo Electron LED GmbH received an FDA warning letter?

No FDA warning letter addressed to the name "Thermo Electron LED GmbH" 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 Thermo Electron LED GmbH received an FDA Form 483?

FDA has published 1 Form 483 for Thermo Electron LED GmbH in its reading room, the most recent dated Mar 20, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Thermo Electron LED GmbH?

The most recent FDA inspection on file ended Mar 20, 2025 at Langenselbold, Germany and was classified NAI. FDA has 3 inspections of Thermo Electron LED GmbH on file.

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