CPF 28275157846
⚠️ Moderate Risk
FEI: 3014691315 • Jaca • BRAZIL
FEI Number
3014691315
Location
Jaca
Country
BRAZILAddress
Rua Carlos Navarro Da C, , Jardim Mesquita, Jaca, , 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is CPF 28275157846's FDA import refusal history?
CPF 28275157846 (FEI: 3014691315) has 2 FDA import refusal record(s) in our database, spanning from 10/12/2018 to 10/12/2018.
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. CPF 28275157846's FEI number is 3014691315.
What types of violations has CPF 28275157846 received?
CPF 28275157846 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 CPF 28275157846 come from?
All FDA import refusal data for CPF 28275157846 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.