Boehringer Ingelheim Backmittel Gmbh
⚠️ Moderate Risk
FEI: 3001175063 • Bingen Am Rhein, Rhineland-Palatinate • GERMANY
FEI Number
3001175063
Location
Bingen Am Rhein, Rhineland-Palatinate
Country
GERMANYAddress
Mainzer Str. 152-160, , Bingen Am Rhein, Rhineland-Palatinate, Germany
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/12/2010 | 61KCS62HOMATROPINE HYDROBROMIDE (A-CHOLINERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 5/20/2008 | 60CCS04EPINEPHRINE (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 3/21/2008 | 61KAS99ANTI-CHOLINERGIC, N.E.C. | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 3/23/2007 | 60CCS09PHENYLEPHRINE HCL (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 1/26/2007 | 60LCS80ERGOTAMINE TARTRATE (ANALGESIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 1/26/2007 | 60LCS80ERGOTAMINE TARTRATE (ANALGESIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 9/22/2006 | 60CCS04EPINEPHRINE (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 6/30/2005 | 60CCS09PHENYLEPHRINE HCL (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 8/9/2004 | 60CIS09PHENYLEPHRINE HCL (ADRENERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 3/12/2004 | 61KCS27HYOSCYAMINE SULFATE (ANTI-CHOLINERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 7/25/2003 | 61KCS99ANTI-CHOLINERGIC, N.E.C. | Baltimore District Office (BLT-DO) | |
| 10/30/2002 | 61KCS27HYOSCYAMINE SULFATE (ANTI-CHOLINERGIC) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Boehringer Ingelheim Backmittel Gmbh's FDA import refusal history?
Boehringer Ingelheim Backmittel Gmbh (FEI: 3001175063) has 12 FDA import refusal record(s) in our database, spanning from 10/30/2002 to 5/12/2010.
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 Backmittel Gmbh's FEI number is 3001175063.
What types of violations has Boehringer Ingelheim Backmittel Gmbh received?
Boehringer Ingelheim Backmittel Gmbh 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 Backmittel Gmbh come from?
All FDA import refusal data for Boehringer Ingelheim Backmittel Gmbh 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.