Boehringer Ingelheim Pharmaceuticals, Inc.
⚠️ High Risk
FEI: 1219205 • Ridgefield, CT • UNITED STATES
FEI Number
1219205
Location
Ridgefield, CT
Country
UNITED STATESAddress
900 Ridgebury Rd, , Ridgefield, CT, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/2/2025 | 61PCA73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 61PDB73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2023 | 60FDY03TALC (ADSORBANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/17/2022 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2022 | 66FDA99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2021 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/19/2021 | 61PCY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2020 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2019 | 61LCY41DABIGATRAN ETEXILATE MESYLATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/26/2019 | 61PDY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2017 | 62YDA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2016 | 62OCY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2015 | 61LCB13WARFARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/21/2009 | 62JDA15PRAMIPEXOLE (ANTI-PARKINSONIAN) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 12/14/2007 | 63BDK26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/16/2006 | 62YCA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/16/2006 | 65PCE03TAMSULOSIN HCL (REGULATOR) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 5/15/2006 | 64LCA56PREDNISONE (GLUCOCORTICOID) | 179AGR RX | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Boehringer Ingelheim Pharmaceuticals, Inc.'s FDA import refusal history?
Boehringer Ingelheim Pharmaceuticals, Inc. (FEI: 1219205) has 18 FDA import refusal record(s) in our database, spanning from 5/15/2006 to 7/2/2025.
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. Boehringer Ingelheim Pharmaceuticals, Inc.'s FEI number is 1219205.
What types of violations has Boehringer Ingelheim Pharmaceuticals, Inc. received?
Boehringer Ingelheim Pharmaceuticals, 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 Boehringer Ingelheim Pharmaceuticals, Inc. come from?
All FDA import refusal data for Boehringer Ingelheim 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.