NIPRO MEDICAL DE MEXICO SA DE
⚠️ Moderate Risk
FEI: 3013148410 • Mexico City • MEXICO
FEI Number
3013148410
Location
Mexico City
Country
MEXICOAddress
Serra Candela NO 111 PI, , 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 |
|---|---|---|---|
| 2/3/2017 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NIPRO MEDICAL DE MEXICO SA DE's FDA import refusal history?
NIPRO MEDICAL DE MEXICO SA DE (FEI: 3013148410) has 1 FDA import refusal record(s) in our database, spanning from 2/3/2017 to 2/3/2017.
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. NIPRO MEDICAL DE MEXICO SA DE's FEI number is 3013148410.
What types of violations has NIPRO MEDICAL DE MEXICO SA DE received?
NIPRO MEDICAL DE MEXICO SA DE 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 NIPRO MEDICAL DE MEXICO SA DE come from?
All FDA import refusal data for NIPRO MEDICAL DE MEXICO SA DE 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.