B.V. Iba S&I
⚠️ Moderate Risk
FEI: 3003473859 • 2722 Zoetermeer • NETHERLANDS
FEI Number
3003473859
Location
2722 Zoetermeer
Country
NETHERLANDSAddress
Stokstraat 8-10, , 2722 Zoetermeer, , Netherlands
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
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 B.V. Iba S&I's FDA import refusal history?
B.V. Iba S&I (FEI: 3003473859) has 2 FDA import refusal record(s) in our database, spanning from 11/18/2001 to 5/16/2002.
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. B.V. Iba S&I's FEI number is 3003473859.
What types of violations has B.V. Iba S&I received?
B.V. Iba S&I 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 B.V. Iba S&I come from?
All FDA import refusal data for B.V. Iba S&I 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.