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Ciblex

✅ Low Risk

FEI: 3004909878 • Gonesse, Val d'Oise • FRANCE

FEI

FEI Number

3004909878

📍

Location

Gonesse, Val d'Oise

🇫🇷

Country

FRANCE
🏢

Address

10 Rue Ampere, , Gonesse, Val d'Oise, France

Low Risk

FDA Import Risk Assessment

23.9
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
1/6/2009
Latest Refusal
7/18/2005
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
5.8×10%
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

1181×

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).

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
1/6/2009
79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)
7/18/2005
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ciblex's FDA import refusal history?

Ciblex (FEI: 3004909878) has 2 FDA import refusal record(s) in our database, spanning from 7/18/2005 to 1/6/2009.

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. Ciblex's FEI number is 3004909878.

What types of violations has Ciblex received?

Ciblex 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 Ciblex come from?

All FDA import refusal data for Ciblex 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.