Uniao Qulmica Farmaceutica Nacio
⚠️ High Risk
FEI: 3007993642 • Embu • BRAZIL
FEI Number
3007993642
Location
Embu
Country
BRAZILAddress
Rua Cel Luiz Tenorio De Brito 90, , Embu, , Brazil
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
Frequently Asked Questions
What is Uniao Qulmica Farmaceutica Nacio's FDA import refusal history?
Uniao Qulmica Farmaceutica Nacio (FEI: 3007993642) has 2 FDA import refusal record(s) in our database, spanning from 10/27/2011 to 6/3/2025.
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. Uniao Qulmica Farmaceutica Nacio's FEI number is 3007993642.
What types of violations has Uniao Qulmica Farmaceutica Nacio received?
Uniao Qulmica Farmaceutica Nacio has been cited for 2 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 Uniao Qulmica Farmaceutica Nacio come from?
All FDA import refusal data for Uniao Qulmica Farmaceutica Nacio 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.