Anteis Sa
⚠️ High Risk
FEI: 3007744205 • Plan-les-ouates, Geneve • SWITZERLAND
FEI Number
3007744205
Location
Plan-les-ouates, Geneve
Country
SWITZERLANDAddress
Chemin Des Aulx, , Plan-les-ouates, Geneve, 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
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 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).
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).
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.
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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).
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/8/2025 | 60QBL07LIDOCAINE | Division of Northeast Imports (DNEI) | |
| 8/4/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 7/16/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/1/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 3/23/2017 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 12/12/2011 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | New Orleans District Office (NOL-DO) | |
| 12/12/2011 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/24/2010 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | New York District Office (NYK-DO) | |
| 3/24/2010 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | New York District Office (NYK-DO) | |
| 3/24/2010 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Anteis Sa's FDA import refusal history?
Anteis Sa (FEI: 3007744205) has 11 FDA import refusal record(s) in our database, spanning from 3/24/2010 to 8/8/2025.
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. Anteis Sa's FEI number is 3007744205.
What types of violations has Anteis Sa received?
Anteis Sa 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 Anteis Sa come from?
All FDA import refusal data for Anteis Sa 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.