GREINER BIO-ONE GMBH/BAD
⚠️ High Risk
FEI: 3014675247 • Kremsmunster, Oberosterreich • AUSTRIA
FEI
FEI Number
3014675247
📍
Location
Kremsmunster, Oberosterreich
🇦🇹
Country
AUSTRIA🏢
Address
Bad Haller Strase 32/A-455, Oberost, Kremsmunster, Oberosterreich, Austria
High Risk
FDA Import Risk Assessment
55.9
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
116
Total Refusals
4
Unique Violations
7/13/2021
Latest Refusal
9/28/2018
Earliest Refusal
Score Breakdown
Violation Severity
52.2×40%
Refusal Volume
76.6×30%
Recency
10.0×20%
Frequency
100.0×10%
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
11899×
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).
50818×
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.
32805×
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.
3414×
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/13/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/13/2021 | 81GHCTUBE, SEDIMENTATION RATE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/13/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/13/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/13/2021 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/13/2021 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 81GHCTUBE, SEDIMENTATION RATE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/18/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/3/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/3/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/3/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/3/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/3/2021 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/3/2021 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/28/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/28/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/28/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/23/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Division of Southeast Imports (DSEI) | |
| 12/23/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Division of Southeast Imports (DSEI) | |
| 12/23/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Division of Southeast Imports (DSEI) | |
| 12/23/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Division of Southeast Imports (DSEI) | |
| 8/24/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Division of Southeast Imports (DSEI) | |
| 8/24/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Division of Southeast Imports (DSEI) | |
| 8/24/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 7/24/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/5/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/5/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/4/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/4/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/4/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/4/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/22/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/22/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/22/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/18/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/18/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/18/2020 | 81GHCTUBE, SEDIMENTATION RATE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/18/2020 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/18/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/18/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/16/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/20/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/5/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/31/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/31/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/31/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/31/2020 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/31/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75JRCMICRO PIPETTE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 81GHCTUBE, SEDIMENTATION RATE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/25/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/25/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/25/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/20/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/20/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/20/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/20/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/21/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/19/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 7/23/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/17/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GREINER BIO-ONE GMBH/BAD's FDA import refusal history?
GREINER BIO-ONE GMBH/BAD (FEI: 3014675247) has 116 FDA import refusal record(s) in our database, spanning from 9/28/2018 to 7/13/2021.
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. GREINER BIO-ONE GMBH/BAD's FEI number is 3014675247.
What types of violations has GREINER BIO-ONE GMBH/BAD received?
GREINER BIO-ONE GMBH/BAD 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 GREINER BIO-ONE GMBH/BAD come from?
All FDA import refusal data for GREINER BIO-ONE GMBH/BAD 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.