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QIAGEN, GMBH FDA Inspection Record

FEI 3004013603 · Inspections, Form 483s, warning letters and import refusals

QIAGEN, GMBH is an FDA-registered facility (FEI 3004013603) located in HILDEN North Rhine-Westphalia, DE. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 12, 2026: No Action Indicated (NAI)
Inspections on record
5 (1 VAI, 4 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
4, latest Aug 22, 2023
Import refusals
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 12, 2026No Action Indicated (NAI)No citations listed
Nov 4, 2022Voluntary Action Indicated (VAI)No citations listed
Feb 9, 2017No Action Indicated (NAI)No citations listed
Aug 27, 2015No Action Indicated (NAI)No citations listed
Sep 26, 2013No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Aug 22, 2023Class IIZ-2665-2023therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx…
Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue…
May 19, 2023Class IIZ-2245-2023QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing… and 1 more product
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be…
May 9, 2023Class IIZ-2215-2023QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and…
If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number…
Jul 22, 2017Class IIZ-0274-2018QIAamp DSP Virus Kit Cat. No. 60704
Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Qiagen GmbH
Location
HILDEN North Rhine-Westphalia (DE)
Source
device

Import refusals

FDA data resources

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