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Dioptrix

⚠️ Moderate Risk

FEI: 3004781307 • L Union, Haute Garonne • FRANCE

FEI

FEI Number

3004781307

📍

Location

L Union, Haute Garonne

🇫🇷

Country

FRANCE
🏢

Address

13 rue d Ariane, , L Union, Haute Garonne, France

Moderate Risk

FDA Import Risk Assessment

34.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/28/2010
Latest Refusal
4/28/2010
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3431×

VET LEGEND

The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).

Refusal History

DateProductViolationsDivision
4/28/2010
68X10SMALL ANIMAL DEVICE/DIAG PROD FOR ANIMAL
16DIRECTIONS
343VET LEGEND
New York District Office (NYK-DO)
4/28/2010
68XYY10SMALL ANIMAL DEVICE/DIAG PROD FOR ANIMAL
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Dioptrix's FDA import refusal history?

Dioptrix (FEI: 3004781307) has 2 FDA import refusal record(s) in our database, spanning from 4/28/2010 to 4/28/2010.

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 3004781307.

What types of violations has Dioptrix received?

Dioptrix 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 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.