GREINER BIO-ONE GMBH
⚠️ Moderate Risk
FEI: 3013312563 • Kremsmunster • AUSTRIA
FEI Number
3013312563
Location
Kremsmunster
Country
AUSTRIAAddress
Postfach 24, a-4550, , Kremsmunster, , Austria
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).
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.
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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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 |
|---|---|---|---|
| 3/19/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/18/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 237NO PMA | Division of Southeast Imports (DSEI) |
| 10/16/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/28/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/20/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/24/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 5/21/2018 | 81GHCTUBE, SEDIMENTATION RATE | Division of Southeast Imports (DSEI) | |
| 5/21/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 4/23/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 4/6/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/30/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 3/30/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/21/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/9/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/2/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/3/2017 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/3/2017 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 80NNICONTAINER, SPECIMEN, NON-STERILE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 81JPHTEST, ERYTHROCYTE SEDIMENTATION RATE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 80FMHCONTAINER, SPECIMEN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 75JRCMICRO PIPETTE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 80FMHCONTAINER, SPECIMEN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2017 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GREINER BIO-ONE GMBH's FDA import refusal history?
GREINER BIO-ONE GMBH (FEI: 3013312563) has 33 FDA import refusal record(s) in our database, spanning from 6/30/2017 to 3/19/2019.
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's FEI number is 3013312563.
What types of violations has GREINER BIO-ONE GMBH received?
GREINER BIO-ONE GMBH has been cited for 6 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 come from?
All FDA import refusal data for GREINER BIO-ONE 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.