Euro Crystals Laboratories
⚠️ Moderate Risk
FEI: 3007319472 • Toulouse • FRANCE
FEI Number
3007319472
Location
Toulouse
Country
FRANCEAddress
Parc Technologique Du Canal Camp, , Toulouse, , France
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
Frequently Asked Questions
What is Euro Crystals Laboratories's FDA import refusal history?
Euro Crystals Laboratories (FEI: 3007319472) has 1 FDA import refusal record(s) in our database, spanning from 7/30/2009 to 7/30/2009.
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. Euro Crystals Laboratories's FEI number is 3007319472.
What types of violations has Euro Crystals Laboratories received?
Euro Crystals Laboratories 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 Euro Crystals Laboratories come from?
All FDA import refusal data for Euro Crystals Laboratories 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.