Aventis Pharma, S.A. De C.V.
⚠️ High Risk
FEI: 3003450798 • Queretaro, QRO. • MEXICO
FEI Number
3003450798
Location
Queretaro, QRO.
Country
MEXICOAddress
Calle 2a # 42 Zona Industrial Benito, , Queretaro, QRO., Mexico
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).
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 |
|---|---|---|---|
| 3/24/2003 | 62FBJ20IODINE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/24/2003 | 64ADQ20TRICLOSAN (DISINFECTANT) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/24/2003 | 64ADJ20TRICLOSAN (DISINFECTANT) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/24/2003 | 64ABR20TRICLOSAN (DISINFECTANT) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/24/2003 | 64ABR20TRICLOSAN (DISINFECTANT) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/24/2003 | 64ABR20TRICLOSAN (DISINFECTANT) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/24/2003 | 60LBJ99ANALGESIC, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/22/2002 | 61WBR39UNDECYLENIC ACID (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/22/2002 | 61WBJ39UNDECYLENIC ACID (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/7/2002 | 53LH04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 56GBJ99ANTIFUNGAL N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 56GBJ99ANTIFUNGAL N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 56GBJ99ANTIFUNGAL N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Aventis Pharma, S.A. De C.V.'s FDA import refusal history?
Aventis Pharma, S.A. De C.V. (FEI: 3003450798) has 13 FDA import refusal record(s) in our database, spanning from 11/27/2001 to 3/24/2003.
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.A. De C.V.'s FEI number is 3003450798.
What types of violations has Aventis Pharma, S.A. De C.V. received?
Aventis Pharma, S.A. De C.V. 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, S.A. De C.V. come from?
All FDA import refusal data for Aventis Pharma, S.A. De C.V. 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.