EUROFINS IMMUNOLAB GMBH
⚠️ Moderate Risk
FEI: 3015726499 • Kassel, Hesse • GERMANY
FEI Number
3015726499
Location
Kassel, Hesse
Country
GERMANYAddress
Otto-Hahn-Str. 16, , Kassel, Hesse, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/20/2017 | 57GH18ALLERGEN PATCH TESTS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/20/2017 | 57GH18ALLERGEN PATCH TESTS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/20/2017 | 57GH18ALLERGEN PATCH TESTS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/20/2017 | 57GH18ALLERGEN PATCH TESTS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/20/2017 | 83GPEANTISERA, POSITIVE CONTROL, ECHINOCOCCUS SPP. | New Orleans District Office (NOL-DO) | |
| 3/2/2016 | 83OJNMYCOBACTERIUM TUBERCULOSIS, CELL MEDIATED IMMUNE RESPONSE, ENZYME-LINKED IMMUNOSPOT TEST | New Orleans District Office (NOL-DO) | |
| 10/6/2014 | 83MWASYSTEM, NUCLEIC ACID AMPLIFICATION, MYCOBACTERIUM TUBERCULOSIS COMPLEX | New Orleans District Office (NOL-DO) | |
| 11/7/2013 | 83NCDTEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS | New Orleans District Office (NOL-DO) | |
| 3/22/2013 | 81MVUREAGENTS, SPECIFIC, ANALYTE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/13/2010 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is EUROFINS IMMUNOLAB GMBH's FDA import refusal history?
EUROFINS IMMUNOLAB GMBH (FEI: 3015726499) has 10 FDA import refusal record(s) in our database, spanning from 8/13/2010 to 3/20/2017.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. EUROFINS IMMUNOLAB GMBH's FEI number is 3015726499.
What types of violations has EUROFINS IMMUNOLAB GMBH received?
EUROFINS IMMUNOLAB GMBH has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about EUROFINS IMMUNOLAB GMBH come from?
All FDA import refusal data for EUROFINS IMMUNOLAB GMBH is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.