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Qoleum Sportscare

⚠️ High Risk

FEI: 3005533645 • Overmere, Oost-Vlaanderen • BELGIUM

FEI

FEI Number

3005533645

📍

Location

Overmere, Oost-Vlaanderen

🇧🇪

Country

BELGIUM
🏢

Address

Heikantstraat 5, , Overmere, Oost-Vlaanderen, Belgium

High Risk

FDA Import Risk Assessment

50.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

13
Total Refusals
1
Unique Violations
6/15/2010
Latest Refusal
6/15/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
42.5×30%
Recency
0.0×20%
Frequency
100.0×10%
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

1613×

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.

Refusal History

DateProductViolationsDivision
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)
6/15/2010
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
16DIRECTIONS
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Qoleum Sportscare's FDA import refusal history?

Qoleum Sportscare (FEI: 3005533645) has 13 FDA import refusal record(s) in our database, spanning from 6/15/2010 to 6/15/2010.

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. Qoleum Sportscare's FEI number is 3005533645.

What types of violations has Qoleum Sportscare received?

Qoleum Sportscare 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 Qoleum Sportscare come from?

All FDA import refusal data for Qoleum Sportscare 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.