ALLERGAN INC.
⚠️ High Risk
FEI: 3040500362 • Kyiv • UKRAINE
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/19/2025 | 58PCY05ONABOTULINUMTOXINA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2025 | 58PCY05ONABOTULINUMTOXINA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2025 | 58PCY05ONABOTULINUMTOXINA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2025 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/12/2025 | 53PB99OTHER COSMETIC RAW MATERIALS, N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is ALLERGAN INC.'s FDA import refusal history?
ALLERGAN INC. (FEI: 3040500362) has 5 FDA import refusal record(s) in our database, spanning from 11/12/2025 to 11/19/2025.
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. ALLERGAN INC.'s FEI number is 3040500362.
What types of violations has ALLERGAN INC. received?
ALLERGAN INC. has been cited for 2 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 INC. come from?
All FDA import refusal data for ALLERGAN INC. 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.