Allergan Sales, LLC
⚠️ High Risk
FEI: 1643525 • Waco, TX • UNITED STATES
FEI Number
1643525
Location
Waco, TX
Country
UNITED STATESAddress
8301 Mars Dr, , Waco, TX, United States
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2025 | 60CDY54BRIMONIDINE TARTRATE (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 64TDY99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/29/2016 | 65LBY99PROTECTANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/29/2012 | 65KCK10BIMATOPROST (PROSTAGLANDIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 61FDK61GATIFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Allergan Sales, LLC's FDA import refusal history?
Allergan Sales, LLC (FEI: 1643525) has 5 FDA import refusal record(s) in our database, spanning from 10/28/2011 to 10/7/2025.
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 Sales, LLC's FEI number is 1643525.
What types of violations has Allergan Sales, LLC received?
Allergan Sales, LLC 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 Sales, LLC come from?
All FDA import refusal data for Allergan Sales, LLC 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.