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Dioptrix

⚠️ Moderate Risk

FEI: 3004597203 • Toulousetoulouse • FRANCE

FEI

FEI Number

3004597203

📍

Location

Toulousetoulouse

🇫🇷

Country

FRANCE
🏢

Address

2 Rue Des Mouettes31400 Toulouse, , Toulousetoulouse, , France

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
12/29/2004
Latest Refusal
12/29/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
12/29/2004
86LZPAID, SURGICAL, VISCOELASTIC
479DV QUALITY
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Dioptrix's FDA import refusal history?

Dioptrix (FEI: 3004597203) has 1 FDA import refusal record(s) in our database, spanning from 12/29/2004 to 12/29/2004.

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. Dioptrix's FEI number is 3004597203.

What types of violations has Dioptrix received?

Dioptrix 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 Dioptrix come from?

All FDA import refusal data for Dioptrix 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.