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Dermotechnology

✅ Low Risk

FEI: 3011498228 • Puget Sur Argens, VAR • FRANCE

FEI

FEI Number

3011498228

📍

Location

Puget Sur Argens, VAR

🇫🇷

Country

FRANCE
🏢

Address

198 chemin des Vernedes, , Puget Sur Argens, VAR, France

Low Risk

FDA Import Risk Assessment

23.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
5/28/2015
Latest Refusal
5/28/2015
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
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

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
5/28/2015
66YCP99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
3280FRNMFGREG
336INCONSPICU
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Dermotechnology's FDA import refusal history?

Dermotechnology (FEI: 3011498228) has 1 FDA import refusal record(s) in our database, spanning from 5/28/2015 to 5/28/2015.

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. Dermotechnology's FEI number is 3011498228.

What types of violations has Dermotechnology received?

Dermotechnology has been cited for 3 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 Dermotechnology come from?

All FDA import refusal data for Dermotechnology 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.