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Allergan France

⚠️ Moderate Risk

FEI: 3010874712 • Courbevoie, Hauts de Seine • FRANCE

FEI

FEI Number

3010874712

📍

Location

Courbevoie, Hauts de Seine

🇫🇷

Country

FRANCE
🏢

Address

12 Place De La Defense, , Courbevoie, Hauts de Seine, France

Moderate Risk

FDA Import Risk Assessment

41.9
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
3
Unique Violations
12/23/2022
Latest Refusal
10/14/2015
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
22.3×30%
Recency
23.9×20%
Frequency
4.2×10%
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

752×

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).

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

32801×

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.

Refusal History

DateProductViolationsDivision
12/23/2022
66VDK99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/7/2017
79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
2480RXPERSONAL
3280FRNMFGREG
Division of Southeast Imports (DSEI)
10/14/2015
65QDY02BOTOX
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Allergan France's FDA import refusal history?

Allergan France (FEI: 3010874712) has 3 FDA import refusal record(s) in our database, spanning from 10/14/2015 to 12/23/2022.

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 France's FEI number is 3010874712.

What types of violations has Allergan France received?

Allergan France has been cited for 3 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 France come from?

All FDA import refusal data for Allergan France 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.