SA DE CV JAOME MONROY
⚠️ High Risk
FEI: 3031056346 • Zapopan • MEXICO
FEI Number
3031056346
Location
Zapopan
Country
MEXICOAddress
Camino Real De Colima #, , Zapopan, , 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 |
|---|---|---|---|
| 7/16/2024 | 54FCA24SENNA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SA DE CV JAOME MONROY's FDA import refusal history?
SA DE CV JAOME MONROY (FEI: 3031056346) has 1 FDA import refusal record(s) in our database, spanning from 7/16/2024 to 7/16/2024.
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. SA DE CV JAOME MONROY's FEI number is 3031056346.
What types of violations has SA DE CV JAOME MONROY received?
SA DE CV JAOME MONROY 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 SA DE CV JAOME MONROY come from?
All FDA import refusal data for SA DE CV JAOME MONROY 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.