Sanofi Pasteur S A De C V
⚠️ High Risk
FEI: 3009141120 • Coyoacan, FN • MEXICO
FEI Number
3009141120
Location
Coyoacan, FN
Country
MEXICOAddress
Av Universidad 1738, Col Coyoacan, Coyoacan, FN, 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).
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2025 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/31/2019 | 61XCB06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2017 | 60LDC82PHENAZOPYRIDINE HCL (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2017 | 64BDB37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/9/2016 | 62UCF11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | Division of Southeast Imports (DSEI) | |
| 8/24/2016 | 56YCB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/16/2016 | 61PCK22NEUTRAL INSULIN (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60SBL23METOCLOPRAMIDE (ANTACID) | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60SBL23METOCLOPRAMIDE (ANTACID) | Florida District Office (FLA-DO) | |
| 5/18/2015 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/18/2015 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/13/2012 | 62GCY46KETOPROFEN (ANTI-INFLAMMATORY) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sanofi Pasteur S A De C V's FDA import refusal history?
Sanofi Pasteur S A De C V (FEI: 3009141120) has 27 FDA import refusal record(s) in our database, spanning from 8/13/2012 to 12/22/2025.
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. Sanofi Pasteur S A De C V's FEI number is 3009141120.
What types of violations has Sanofi Pasteur S A De C V received?
Sanofi Pasteur 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 Sanofi Pasteur S A De C V come from?
All FDA import refusal data for Sanofi Pasteur 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.