Christian Dalloz S.A.
✅ Low Risk
FEI: 7223 • Saint Claude • FRANCE
FEI Number
7223
Location
Saint Claude
Country
FRANCEAddress
Route De Geneve, BP 168, Saint Claude, , France
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2001 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Christian Dalloz S.A.'s FDA import refusal history?
Christian Dalloz S.A. (FEI: 7223) has 1 FDA import refusal record(s) in our database, spanning from 12/11/2001 to 12/11/2001.
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. Christian Dalloz S.A.'s FEI number is 7223.
What types of violations has Christian Dalloz S.A. received?
Christian Dalloz 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 Christian Dalloz S.A. come from?
All FDA import refusal data for Christian Dalloz 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.