Schering Mexicana Sa
⚠️ Moderate Risk
FEI: 3004437292 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3004437292
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calzada Mexico Xochimilco 5019, Pueblo San Lorenzo Huipulco, Tlalpan, Ciudad De Mexico, Ciudad de Mexico, 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 |
|---|---|---|---|
| 5/5/2005 | 64GDA13ESTRADIOL VALERATE (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/18/2005 | 64LDM50PREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/18/2005 | 64LDM50PREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Schering Mexicana Sa's FDA import refusal history?
Schering Mexicana Sa (FEI: 3004437292) has 3 FDA import refusal record(s) in our database, spanning from 2/18/2005 to 5/5/2005.
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. Schering Mexicana Sa's FEI number is 3004437292.
What types of violations has Schering Mexicana Sa received?
Schering Mexicana Sa 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 Schering Mexicana Sa come from?
All FDA import refusal data for Schering Mexicana Sa 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.