Allergan
⚠️ Moderate Risk
FEI: 3011721318 • Courbevoie, Hauts de Seine • FRANCE
FEI Number
3011721318
Location
Courbevoie, Hauts de Seine
Country
FRANCEAddress
12 place de la Defense, , Courbevoie, Hauts de Seine, France
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
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).
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.
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.
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/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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/9/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 9/23/2016 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | New York District Office (NYK-DO) | |
| 8/4/2016 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2380NO PMA/PDP | New Orleans District Office (NOL-DO) |
| 8/1/2016 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | New Orleans District Office (NOL-DO) |
| 5/25/2016 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Allergan's FDA import refusal history?
Allergan (FEI: 3011721318) has 5 FDA import refusal record(s) in our database, spanning from 5/25/2016 to 8/9/2018.
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. Allergan's FEI number is 3011721318.
What types of violations has Allergan received?
Allergan 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 Allergan come from?
All FDA import refusal data for Allergan 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.