Aventis Pharma
⚠️ High Risk
FEI: 3004581395 • Guatemala, Guatemala • GUATEMALA
FEI Number
3004581395
Location
Guatemala, Guatemala
Country
GUATEMALAAddress
Km 15,5 Carr Roosevelt z. 7, , Guatemala, Guatemala, Guatemala
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 11/13/2025 | 60LCB21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 60LCA21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/5/2017 | 61EDB06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/16/2016 | 62LCB29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Florida District Office (FLA-DO) | |
| 10/7/2015 | 56YBL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2011 | 64BDA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/5/2007 | 66VIF99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/10/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/1/2006 | 62CBB64ACCURETIC (ANTI-HYPERTENSIVE) | Florida District Office (FLA-DO) | |
| 5/5/2005 | 61MCB99ANTI-CONVULSANT, N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Aventis Pharma's FDA import refusal history?
Aventis Pharma (FEI: 3004581395) has 10 FDA import refusal record(s) in our database, spanning from 5/5/2005 to 11/13/2025.
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. Aventis Pharma's FEI number is 3004581395.
What types of violations has Aventis Pharma received?
Aventis Pharma has been cited for 3 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 Aventis Pharma come from?
All FDA import refusal data for Aventis Pharma 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.