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Kontak Di Fabretto

⚠️ Moderate Risk

FEI: 3006027550 • Turin, Turin • ITALY

FEI

FEI Number

3006027550

📍

Location

Turin, Turin

🇮🇹

Country

ITALY
🏢

Address

Corso Principe Oddone 88, , Turin, Turin, Italy

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
2/23/2010
Latest Refusal
2/23/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

5084×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

754×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
2/23/2010
80LRJDISINFECTANT, MEDICAL DEVICES
508NO 510(K)
75UNAPPROVED
Southwest Import District Office (SWI-DO)
2/23/2010
80LRJDISINFECTANT, MEDICAL DEVICES
508NO 510(K)
75UNAPPROVED
Southwest Import District Office (SWI-DO)
2/23/2010
80LRJDISINFECTANT, MEDICAL DEVICES
508NO 510(K)
75UNAPPROVED
Southwest Import District Office (SWI-DO)
2/23/2010
80LRJDISINFECTANT, MEDICAL DEVICES
508NO 510(K)
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Kontak Di Fabretto's FDA import refusal history?

Kontak Di Fabretto (FEI: 3006027550) has 4 FDA import refusal record(s) in our database, spanning from 2/23/2010 to 2/23/2010.

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. Kontak Di Fabretto's FEI number is 3006027550.

What types of violations has Kontak Di Fabretto received?

Kontak Di Fabretto 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 Kontak Di Fabretto come from?

All FDA import refusal data for Kontak Di Fabretto 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.