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Ferrosan Medical Devices A/S FDA Record

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

Ferrosan Medical Devices A/S has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Ferrosan Medical Devices A/S, the most recent on Sep 16, 2015.

What these totals cover: FDA records filed under the name "Ferrosan Medical Devices A/S" and its spelling variant "Ferrosan Medical Devices". Records filed under related names are not included; see Related names.

Latest inspection: Jan 29, 2016 · 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	1	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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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 Ferrosan Medical Devices A/S above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Ferrosan Medical Devices Sp. Z O. O Combines 2 spellings Ferrosan Medical Devices Sp. Z O. O: 3 inspections Ferrosan Medical Devices Sp. Z.O.O: 1 510(k)	Same company group	0	1	3	0	—

Ferrosan Medical Devices A/S FDA Warning Letters

1 warning letter on Sep 16, 2015.

Issued	Subject	Issuing office	Close-out letter
Sep 16, 2015

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

1 inspection on Jan 29, 2016.

Date	Site	Product	Classification	FEI
Jan 29, 2016	Soborg, Denmark	Food/Cosmetics	Voluntary Action Indicated (VAI)	3008478369

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 Ferrosan Medical Devices A/S: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 16, 2015.

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 3008478369	Soborg, Denmark	1	Jan 29, 2016

Ferrosan Medical Devices A/S and the FDA: common questions

Has Ferrosan Medical Devices A/S received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Ferrosan Medical Devices A/S. The most recent is dated Sep 16, 2015.

Has Ferrosan Medical Devices A/S received an FDA Form 483?

FDA has not published a Form 483 for "Ferrosan Medical Devices A/S" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Ferrosan Medical Devices A/S?

The most recent FDA inspection on file ended Jan 29, 2016 at Soborg, Denmark and was classified VAI. FDA has 1 inspection of Ferrosan Medical Devices A/S on file.

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