Teoxane S.A.
⚠️ High Risk
FEI: 3005975625 • Geneva, Geneva • SWITZERLAND
FEI Number
3005975625
Location
Geneva, Geneva
Country
SWITZERLANDAddress
Rue De Lyon 105, , Geneva, Geneva, Switzerland
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
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).
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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.
3904
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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).
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).
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 10/24/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 7/11/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 7/11/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 7/11/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 11/22/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/27/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/18/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 9/11/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 8/12/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southwest Imports (DSWI) | |
| 7/22/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 3/1/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 39043904 | Division of West Coast Imports (DWCI) |
| 3/1/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 39043904 | Division of West Coast Imports (DWCI) |
| 3/1/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 39043904 | Division of West Coast Imports (DWCI) |
| 9/19/2023 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2380NO PMA/PDP | Division of Northern Border Imports (DNBI) |
| 7/20/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 60QBY07LIDOCAINE | Division of Northern Border Imports (DNBI) | |
| 1/8/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of Southeast Imports (DSEI) |
| 7/15/2020 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 10/25/2018 | 78PNRENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS | 237NO PMA | Division of Northern Border Imports (DNBI) |
| 7/9/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 3/31/2017 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/7/2017 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 1/18/2017 | 66YAL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/14/2015 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 8/14/2015 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 8/14/2015 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 6/11/2012 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | New Orleans District Office (NOL-DO) | |
| 10/18/2011 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/21/2010 | 80FMFSYRINGE, PISTON | New York District Office (NYK-DO) | |
| 6/29/2007 | 75LZXACID, SODIUM HYALURONIC | 237NO PMA | New Orleans District Office (NOL-DO) |
| 6/29/2007 | 75LZXACID, SODIUM HYALURONIC | 237NO PMA | New Orleans District Office (NOL-DO) |
| 6/29/2007 | 75LZXACID, SODIUM HYALURONIC | 237NO PMA | New Orleans District Office (NOL-DO) |
| 6/29/2007 | 75LZXACID, SODIUM HYALURONIC | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Teoxane S.A.'s FDA import refusal history?
Teoxane S.A. (FEI: 3005975625) has 34 FDA import refusal record(s) in our database, spanning from 6/29/2007 to 11/21/2025.
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. Teoxane S.A.'s FEI number is 3005975625.
What types of violations has Teoxane S.A. received?
Teoxane S.A. has been cited for 11 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 Teoxane S.A. come from?
All FDA import refusal data for Teoxane S.A. 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.