Sintefina Industria E Comercio Ltda
⚠️ Moderate Risk
FEI: 3004572160 • Diadema, Sao Paulo • BRAZIL
FEI Number
3004572160
Location
Diadema, Sao Paulo
Country
BRAZILAddress
Rua Almirante Cockrane 207 E 227, , Diadema, Sao Paulo, Brazil
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 Sintefina Industria E Comercio Ltda's FDA import refusal history?
Sintefina Industria E Comercio Ltda (FEI: 3004572160) has 2 FDA import refusal record(s) in our database, spanning from 8/26/2004 to 9/19/2005.
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. Sintefina Industria E Comercio Ltda's FEI number is 3004572160.
What types of violations has Sintefina Industria E Comercio Ltda received?
Sintefina Industria E Comercio Ltda 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 Sintefina Industria E Comercio Ltda come from?
All FDA import refusal data for Sintefina Industria E Comercio Ltda 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.