Serag-Wiessner Gmbh
⚠️ High Risk
FEI: 3002808122 • Naila • 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
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.
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.
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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).
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 |
|---|---|---|---|
| 8/1/2025 | 79DZGSUTURE, DENTAL | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/10/2024 | 79GAOSUTURE, NONABSORBABLE | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 3/19/2024 | 79DZGSUTURE, DENTAL | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 11/17/2023 | 79DZGSUTURE, DENTAL | Division of Northern Border Imports (DNBI) | |
| 11/17/2023 | 79DZGSUTURE, DENTAL | Division of Northern Border Imports (DNBI) | |
| 11/2/2023 | 79GAKSUTURE, ABSORBABLE | Division of Southeast Imports (DSEI) | |
| 2/8/2023 | 79MXWSUTURE, SURGICAL, NONABSORBABLE, POLY (VINYLIDENE FLUORIDE) | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 5/18/2022 | 79DZGSUTURE, DENTAL | Division of Southeast Imports (DSEI) | |
| 5/18/2022 | 79DZGSUTURE, DENTAL | Division of Southeast Imports (DSEI) | |
| 5/18/2022 | 79DZGSUTURE, DENTAL | Division of Southeast Imports (DSEI) | |
| 5/9/2019 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 3/14/2019 | 79DTHSUTURE, CARDIOVASCULAR | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 2/8/2019 | 79DZGSUTURE, DENTAL | Division of Southeast Imports (DSEI) | |
| 2/8/2019 | 79DZGSUTURE, DENTAL | Division of Southeast Imports (DSEI) | |
| 7/27/2018 | 76LYCBONE GRAFTING MATERIAL, SYNTHETIC | Division of Southeast Imports (DSEI) | |
| 7/3/2018 | 79GAOSUTURE, NONABSORBABLE | Division of Southeast Imports (DSEI) | |
| 10/9/2015 | 79MXWSUTURE, SURGICAL, NONABSORBABLE, POLY (VINYLIDENE FLUORIDE) | New Orleans District Office (NOL-DO) | |
| 9/22/2015 | 79GAOSUTURE, NONABSORBABLE | New Orleans District Office (NOL-DO) | |
| 8/28/2015 | 74DXZPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE | New Orleans District Office (NOL-DO) | |
| 8/19/2015 | 79DZGSUTURE, DENTAL | New Orleans District Office (NOL-DO) | |
| 7/21/2015 | 79NBYSUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE | New Orleans District Office (NOL-DO) | |
| 1/22/2014 | 79DZGSUTURE, DENTAL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Serag-Wiessner Gmbh's FDA import refusal history?
Serag-Wiessner Gmbh (FEI: 3002808122) has 22 FDA import refusal record(s) in our database, spanning from 1/22/2014 to 8/1/2025.
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. Serag-Wiessner Gmbh's FEI number is 3002808122.
What types of violations has Serag-Wiessner Gmbh received?
Serag-Wiessner Gmbh has been cited for 8 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 Serag-Wiessner Gmbh come from?
All FDA import refusal data for Serag-Wiessner 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.