Laboratoires Vivacy
⚠️ High Risk
FEI: 3012285174 • Archamps, Haute Savoie • FRANCE
FEI Number
3012285174
Location
Archamps, Haute Savoie
Country
FRANCEAddress
252 Rue Douglas Engelbart, , Archamps, Haute Savoie, France
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 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).
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.
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.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 10/29/2025 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/9/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 8/4/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northeast Imports (DNEI) | |
| 3/19/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 3/19/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 9/18/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 7/26/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 7/22/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 4/11/2024 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/1/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of Northeast Imports (DNEI) |
| 12/4/2019 | 60QAO67LIDOCAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 6/26/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 6/19/2017 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 6/19/2017 | 60QCK67LIDOCAINE (ANESTHETIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratoires Vivacy's FDA import refusal history?
Laboratoires Vivacy (FEI: 3012285174) has 15 FDA import refusal record(s) in our database, spanning from 6/19/2017 to 12/8/2025.
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. Laboratoires Vivacy's FEI number is 3012285174.
What types of violations has Laboratoires Vivacy received?
Laboratoires Vivacy has been cited for 9 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 Laboratoires Vivacy come from?
All FDA import refusal data for Laboratoires Vivacy 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.