ALTRUAN GMBH
⚠️ High Risk
FEI: 3035369407 • Massing • GERMANY
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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 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.
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 PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Northern Border Imports (DNBI) | |
| 11/14/2025 | 88PPMGENERAL PURPOSE REAGENT | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 11/13/2025 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southwest Imports (DSWI) | |
| 11/12/2025 | 83OTTRESEARCH USE ONLY/MICROBIOLOGY | Division of Southeast Imports (DSEI) | |
| 10/30/2025 | 88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS | Division of Southwest Imports (DSWI) | |
| 10/29/2025 | 88PPMGENERAL PURPOSE REAGENT | Division of Northern Border Imports (DNBI) | |
| 10/28/2025 | 88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS | Division of Southwest Imports (DSWI) | |
| 10/24/2025 | 83QVFA SIMPLE POINT-OF-CARE DEVICE TO DIRECTLY DETECT SARS-COV-2 VIRAL TARGETS FROM CLINICAL SPECIMENS IN | Division of Northeast Imports (DNEI) | |
| 10/22/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of West Coast Imports (DWCI) | |
| 10/22/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of West Coast Imports (DWCI) | |
| 10/22/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of West Coast Imports (DWCI) | |
| 7/15/2025 | 77NRKKIT, TEST, OLFACTORY | Division of Southeast Imports (DSEI) | |
| 6/11/2025 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 6/1/2025 | 77NRKKIT, TEST, OLFACTORY | Division of Southeast Imports (DSEI) | |
| 5/28/2025 | 88PPMGENERAL PURPOSE REAGENT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 88PPMGENERAL PURPOSE REAGENT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/14/2025 | 83PSZDEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS | Division of Southeast Imports (DSEI) | |
| 5/2/2025 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 5/1/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 4/23/2025 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/22/2025 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 4/22/2025 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 4/14/2025 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 4/14/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 4/9/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/1/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 3/25/2025 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | Division of Southeast Imports (DSEI) | |
| 3/25/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 3/24/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ALTRUAN GMBH's FDA import refusal history?
ALTRUAN GMBH (FEI: 3035369407) has 30 FDA import refusal record(s) in our database, spanning from 3/24/2025 to 12/1/2025.
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. ALTRUAN GMBH's FEI number is 3035369407.
What types of violations has ALTRUAN GMBH received?
ALTRUAN GMBH has been cited for 5 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 ALTRUAN GMBH come from?
All FDA import refusal data for ALTRUAN 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.