Boehringer Ingelheim Pharma GmbH & Co. KG
🚨 Critical Risk
FEI: 3002806556 • Ingelheim am Rhein, Rhineland-Palatinate • GERMANY
FEI Number
3002806556
Location
Ingelheim am Rhein, Rhineland-Palatinate
Country
GERMANYAddress
Boehringer Ingelheim KG., Binger Str. 173, Ingelheim am Rhein, Rhineland-Palatinate, Germany
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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).
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.
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2025 | 62ODY18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 10/21/2025 | 61PCY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 61ECQ99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 61ECQ99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 61PCY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 61PCY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/23/2025 | 61PAA73EMPAGLIFLOZIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 7/11/2025 | 61PCY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/7/2025 | 60TCH99ANTAGONIST, N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/13/2025 | 61PCA73EMPAGLIFLOZIN (ANTI-DIABETIC) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 10/2/2024 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/10/2024 | 61PDA73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/23/2024 | 61PDA73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 61PCB73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/28/2023 | 61PDA73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/13/2022 | 62JDA15PRAMIPEXOLE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/7/2022 | 80NSCINJECTOR, PEN | Division of Southeast Imports (DSEI) | |
| 7/7/2022 | 80NKNSYRINGE, PISTON, REPROCESSED | Division of Southeast Imports (DSEI) | |
| 4/7/2022 | 61PCY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2022 | 61PCY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2021 | 62OCY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/4/2021 | 62YCY07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2021 | 61PDY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/19/2020 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2020 | 63BDY26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/29/2020 | 60CDY99ADRENERGIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/17/2020 | 61PDA66LINAGLIPTIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2018 | 61KDS05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/12/2018 | 61PDA66LINAGLIPTIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/23/2018 | 61LCY41DABIGATRAN ETEXILATE MESYLATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2016 | 61PCA66LINAGLIPTIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2016 | 61LCB41DABIGATRAN ETEXILATE MESYLATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2016 | 62YCB07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 12/14/2015 | 61PIS55METFORMIN HCL (ANTI-DIABETIC) | New Orleans District Office (NOL-DO) | |
| 12/2/2015 | 77KCOINHALER, NASAL | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 10/22/2014 | 61KCS05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/4/2014 | 61KCS05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/26/2013 | 60CCS04EPINEPHRINE (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 9/26/2013 | 60CCS04EPINEPHRINE (ADRENERGIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/20/2013 | 60CCS04EPINEPHRINE (ADRENERGIC) | New York District Office (NYK-DO) | |
| 9/20/2013 | 60CCS04EPINEPHRINE (ADRENERGIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/20/2013 | 60CCS04EPINEPHRINE (ADRENERGIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/18/2013 | 60CCS09PHENYLEPHRINE HCL (ADRENERGIC) | Baltimore District Office (BLT-DO) | |
| 12/12/2012 | 61KLY27HYOSCYAMINE SULFATE (ANTI-CHOLINERGIC) | Atlanta District Office (ATL-DO) | |
| 12/11/2012 | 60XCS01DIHYDROERGOTAMINE MESYLATE (ANTI-ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 12/11/2012 | 61KCS24HOMATROPINE METHYLBROMIDE (ANTI-CHOLINERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 9/20/2012 | 60CCS09PHENYLEPHRINE HCL (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 9/20/2012 | 60CCS09PHENYLEPHRINE HCL (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 7/26/2012 | 61LCS99ANTI-COAGULANT, N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 6/18/2012 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/18/2012 | 62KAA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/18/2012 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/10/2012 | 61LIS99ANTI-COAGULANT, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/10/2012 | 61LIS99ANTI-COAGULANT, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/28/2011 | 64BCE25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/28/2011 | 62OCA23CLONIDINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/18/2011 | 64UIS99INHIBITOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/18/2011 | 66NDB04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/18/2011 | 60CCS32EPINEPHRINE BITARTRATE (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 3/11/2011 | 63BCQ08FENOTEROL (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/7/2011 | 60CCS32EPINEPHRINE BITARTRATE (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 2/4/2011 | 61TAY29SCOPOLAMINE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 10/4/2010 | 60CCS99ADRENERGIC N.E.C. | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 9/22/2010 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2010 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/24/2010 | 61KCS99ANTI-CHOLINERGIC, N.E.C. | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 3/15/2010 | 61KCS99ANTI-CHOLINERGIC, N.E.C. | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 10/26/2009 | 63FCS06DIGOXIN (CARDIOTONIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 9/3/2009 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/22/2009 | 62VCA34NEVIRAPINE (ANTI-VIRAL) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 9/3/2008 | 62OAP09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/20/2008 | 61KCS99ANTI-CHOLINERGIC, N.E.C. | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 3/4/2008 | 60CCS32EPINEPHRINE BITARTRATE (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 1/14/2008 | 61LDS05DICUMAROL (ANTI-COAGULANT) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 1/14/2008 | 61LDS05DICUMAROL (ANTI-COAGULANT) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 9/12/2007 | 61KCS99ANTI-CHOLINERGIC, N.E.C. | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 8/20/2007 | 61KCS62HOMATROPINE HYDROBROMIDE (A-CHOLINERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 8/17/2007 | 60CCS32EPINEPHRINE BITARTRATE (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 7/11/2007 | 68YIA99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 6/15/2007 | 61KCS27HYOSCYAMINE SULFATE (ANTI-CHOLINERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 6/7/2007 | 61KCS24HOMATROPINE METHYLBROMIDE (ANTI-CHOLINERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 5/24/2007 | 61KCS24HOMATROPINE METHYLBROMIDE (ANTI-CHOLINERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 3/30/2007 | 62VIS99ANTI-VIRAL N.E.C. | Baltimore District Office (BLT-DO) | |
| 1/9/2007 | 60CCS09PHENYLEPHRINE HCL (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 9/22/2006 | 60CCS32EPINEPHRINE BITARTRATE (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 9/22/2006 | 61KAS99ANTI-CHOLINERGIC, N.E.C. | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 7/26/2006 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2005 | 62ODB09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/11/2005 | 65BAY99MUCOLYTIC N.E.C. | Florida District Office (FLA-DO) | |
| 10/3/2005 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/24/2005 | 62CDY99ANTI-HYPERTENSIVE N.E.C. | San Francisco District Office (SAN-DO) | |
| 3/24/2005 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/21/2004 | 63BRQ99BRONCHODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/17/2004 | 63BCK99BRONCHODILATOR N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/29/2004 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/23/2004 | 64GCA17ESTERIFIED ESTROGENS (ESTROGENS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/2/2004 | 63BRQ99BRONCHODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/18/2003 | 63BRQ99BRONCHODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Boehringer Ingelheim Pharma GmbH & Co. KG's FDA import refusal history?
Boehringer Ingelheim Pharma GmbH & Co. KG (FEI: 3002806556) has 101 FDA import refusal record(s) in our database, spanning from 3/19/2002 to 11/25/2025.
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 Pharma GmbH & Co. KG's FEI number is 3002806556.
What types of violations has Boehringer Ingelheim Pharma GmbH & Co. KG received?
Boehringer Ingelheim Pharma GmbH & Co. KG has been cited for 10 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 Pharma GmbH & Co. KG come from?
All FDA import refusal data for Boehringer Ingelheim Pharma GmbH & Co. KG 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.