Eurofins Biopharma Product Testing, Denmark A/S FDA Record

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

Eurofins Biopharma Product Testing, Denmark A/S has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Eurofins Biopharma Product Testing, Denmark A/S" is on file.

What these totals cover: FDA records filed under the name "Eurofins Biopharma Product Testing, Denmark A/S" and its spelling variant "Eurofins Biopharma Product Testing, Denmark".

Latest inspection
May 17, 2023 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

5 inspections from May 12, 2009 to May 17, 2023.

DateSiteProductClassificationFEI
May 17, 2023Glostrup, DenmarkDrugsNo Action Indicated (NAI)3006272083
Jun 22, 2016Glostrup, DenmarkDrugsVoluntary Action Indicated (VAI)3006272083
Dec 14, 2012Glostrup, DenmarkDrugsVoluntary Action Indicated (VAI)3006272083
Mar 30, 2012Glostrup, DenmarkDrugsNo Action Indicated (NAI)3006272083
May 12, 2009Glostrup, DenmarkDrugsVoluntary Action Indicated (VAI)3006272083
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.

FacilityLocationInspectionsLatest
FEI 3006272083Glostrup, Denmark5May 17, 2023

Eurofins Biopharma Product Testing, Denmark A/S and the FDA: common questions

Has Eurofins Biopharma Product Testing, Denmark A/S received an FDA warning letter?

No FDA warning letter addressed to the name "Eurofins Biopharma Product Testing, Denmark A/S" 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, Denmark A/S received an FDA Form 483?

FDA has not published a Form 483 for "Eurofins Biopharma Product Testing, Denmark A/S" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Eurofins Biopharma Product Testing, Denmark A/S?

The most recent FDA inspection on file ended May 17, 2023 at Glostrup, Denmark and was classified NAI. FDA has 5 inspections of Eurofins Biopharma Product Testing, Denmark A/S on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.