Imelda Cortes Magdaleno
⚠️ High Risk
FEI: 3011442037 • Guadalajaraguadalajara • MEXICO
FEI Number
3011442037
Location
Guadalajaraguadalajara
Country
MEXICOAddress
Zaragoza #30 Interior A Guadalajara, , Guadalajaraguadalajara, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2015 | 66SCA05FLUNARIZINE HCL (VASODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/29/2015 | 56DDA40NEOMYCIN (AMINOGLYCOSIDES) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/29/2015 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/29/2015 | 61HDA03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/29/2015 | 60LDA21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/29/2015 | 56BCE05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/29/2015 | 62GAA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/29/2015 | 60SAK10MAGALDRATE (ANTACID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/29/2015 | 60SAY10MAGALDRATE (ANTACID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Imelda Cortes Magdaleno's FDA import refusal history?
Imelda Cortes Magdaleno (FEI: 3011442037) has 9 FDA import refusal record(s) in our database, spanning from 4/29/2015 to 4/29/2015.
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. Imelda Cortes Magdaleno's FEI number is 3011442037.
What types of violations has Imelda Cortes Magdaleno received?
Imelda Cortes Magdaleno 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 Imelda Cortes Magdaleno come from?
All FDA import refusal data for Imelda Cortes Magdaleno 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.