Spatz FGIA, Inc
✅ Low Risk
FEI: 3015409025 • Ra'Anana, Central • ISRAEL
FEI Number
3015409025
Location
Ra'Anana, Central
Country
ISRAELAddress
2, Ha-Tidhar, , Ra'Anana, Central, Israel
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Spatz FGIA, Inc's FDA import refusal history?
Spatz FGIA, Inc (FEI: 3015409025) has 1 FDA import refusal record(s) in our database, spanning from 12/2/2016 to 12/2/2016.
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. Spatz FGIA, Inc's FEI number is 3015409025.
What types of violations has Spatz FGIA, Inc received?
Spatz FGIA, Inc 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 Spatz FGIA, Inc come from?
All FDA import refusal data for Spatz FGIA, Inc 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.