Boehringer Ingelheim Espana S.A.
⚠️ Moderate Risk
FEI: 3008772184 • Sant Cugat Del Valles, Barcelona • SPAIN
FEI Number
3008772184
Location
Sant Cugat Del Valles, Barcelona
Country
SPAINAddress
Calle Prat De La Riba 50, , Sant Cugat Del Valles, Barcelona, Spain
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
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).
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).
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.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2018 | 61KCP25HYOSCYAMINE (ANTI-CHOLINERGIC) | Division of Southeast Imports (DSEI) | |
| 3/14/2014 | 63BIR99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/11/2013 | 66BCY99STIMULANT N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/12/2012 | 64HBL01BROMHEXINE HCL (EXPECTORANT) | 472NO ENGLISH | New York District Office (NYK-DO) |
| 6/23/2010 | 66VRY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/8/2006 | 60LBF21DIPYRONE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 64HCY01BROMHEXINE HCL (EXPECTORANT) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Boehringer Ingelheim Espana S.A.'s FDA import refusal history?
Boehringer Ingelheim Espana S.A. (FEI: 3008772184) has 7 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 3/9/2018.
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 Espana S.A.'s FEI number is 3008772184.
What types of violations has Boehringer Ingelheim Espana S.A. received?
Boehringer Ingelheim Espana S.A. has been cited for 6 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 Espana S.A. come from?
All FDA import refusal data for Boehringer Ingelheim Espana S.A. 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.