ALLERGAN SALES, LLC
⚠️ Moderate Risk
FEI: 3012867780 • Madison, NJ • UNITED STATES
FEI Number
3012867780
Location
Madison, NJ
Country
UNITED STATESAddress
5 Giralda Farms, , Madison, NJ, United States
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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/22/2023 | 64DDK01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/14/2019 | 65QCY02BOTOX | Division of Southeast Imports (DSEI) | |
| 7/27/2017 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is ALLERGAN SALES, LLC's FDA import refusal history?
ALLERGAN SALES, LLC (FEI: 3012867780) has 3 FDA import refusal record(s) in our database, spanning from 7/27/2017 to 3/22/2023.
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 3012867780.
What types of violations has ALLERGAN SALES, LLC received?
ALLERGAN SALES, LLC 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 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.