Ivens S.A.
⚠️ Moderate Risk
FEI: 3007142721 • Nunoa • CHILE
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
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2008 | 95RZNGENERAL INDUSTRIAL USE MATERIAL PROCESSING LASER PRODUCTS | 47NON STD | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ivens S.A.'s FDA import refusal history?
Ivens S.A. (FEI: 3007142721) has 1 FDA import refusal record(s) in our database, spanning from 10/7/2008 to 10/7/2008.
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. Ivens S.A.'s FEI number is 3007142721.
What types of violations has Ivens S.A. received?
Ivens S.A. 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 Ivens S.A. come from?
All FDA import refusal data for Ivens S.A. 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.