Regeneron Pharmaceuticals Inc
⚠️ High Risk
FEI: 1000514603 • Rensselaer, NY • UNITED STATES
FEI Number
1000514603
Location
Rensselaer, NY
Country
UNITED STATESAddress
81 Columbia Tpke, , Rensselaer, NY, 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
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.
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2025 | 58ACP02DUPILUMAB | 179AGR RX | Division of West Coast Imports (DWCI) |
| 9/17/2025 | 58ADL02DUPILUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/26/2018 | 60YCP01AFLIBERCEPT (INHIBITOR (GROWTH FACTOR)) | Division of Southeast Imports (DSEI) | |
| 6/20/2017 | 64FCK99ENZYME INHIBITOR N.E.C. | 179AGR RX | Division of Northeast Imports (DNEI) |
| 6/20/2017 | 64FCK99ENZYME INHIBITOR N.E.C. | 179AGR RX | Division of Northeast Imports (DNEI) |
| 6/20/2017 | 64FCK99ENZYME INHIBITOR N.E.C. | 179AGR RX | Division of Northeast Imports (DNEI) |
| 9/15/2016 | 64UIK99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2016 | 64UIK99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Regeneron Pharmaceuticals Inc's FDA import refusal history?
Regeneron Pharmaceuticals Inc (FEI: 1000514603) has 8 FDA import refusal record(s) in our database, spanning from 9/15/2016 to 11/3/2025.
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. Regeneron Pharmaceuticals Inc's FEI number is 1000514603.
What types of violations has Regeneron Pharmaceuticals Inc received?
Regeneron Pharmaceuticals Inc has been cited for 4 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 Regeneron Pharmaceuticals Inc come from?
All FDA import refusal data for Regeneron Pharmaceuticals 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.