Offenbach Mexicana, S.A. De C.V.
⚠️ Moderate Risk
FEI: 14451 • Mexico City • MEXICO
FEI Number
14451
Location
Mexico City
Country
MEXICOAddress
Acueducto No. 15, Col Reforma Social, Mexico City, , Mexico
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/12/2021 | 62GCA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2017 | 61HDB43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/9/2016 | 61TCL11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2016 | 66FCB99SUPPRESSANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Offenbach Mexicana, S.A. De C.V.'s FDA import refusal history?
Offenbach Mexicana, S.A. De C.V. (FEI: 14451) has 4 FDA import refusal record(s) in our database, spanning from 6/29/2016 to 3/12/2021.
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. Offenbach Mexicana, S.A. De C.V.'s FEI number is 14451.
What types of violations has Offenbach Mexicana, S.A. De C.V. received?
Offenbach Mexicana, S.A. De C.V. has been cited for 1 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 Offenbach Mexicana, S.A. De C.V. come from?
All FDA import refusal data for Offenbach Mexicana, 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.