ROSA AMALIA RODRIGUEZ
⚠️ Moderate Risk
FEI: 3014230113 • San Pedro Sula, Cortes • HONDURAS
FEI Number
3014230113
Location
San Pedro Sula, Cortes
Country
HONDURASAddress
Santa Lucia La Labor, Calle Real Centenario, San Pedro Sula, Cortes, Honduras
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 |
|---|---|---|---|
| 3/15/2018 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2018 | 61PCY55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2018 | 62ODY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ROSA AMALIA RODRIGUEZ's FDA import refusal history?
ROSA AMALIA RODRIGUEZ (FEI: 3014230113) has 3 FDA import refusal record(s) in our database, spanning from 3/15/2018 to 3/15/2018.
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. ROSA AMALIA RODRIGUEZ's FEI number is 3014230113.
What types of violations has ROSA AMALIA RODRIGUEZ received?
ROSA AMALIA RODRIGUEZ 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 ROSA AMALIA RODRIGUEZ come from?
All FDA import refusal data for ROSA AMALIA RODRIGUEZ 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.