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SanUp

⚠️ Moderate Risk

FEI: 3004127824 • Aywaille, Liege • BELGIUM

FEI

FEI Number

3004127824

📍

Location

Aywaille, Liege

🇧🇪

Country

BELGIUM
🏢

Address

Rue De Lorce 45, , Aywaille, Liege, Belgium

Moderate Risk

FDA Import Risk Assessment

31.9
LowModerateHighCritical

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

Statistics

9
Total Refusals
1
Unique Violations
9/22/2014
Latest Refusal
10/1/2003
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
8.2×10%
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

1189×

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).

Refusal History

DateProductViolationsDivision
9/22/2014
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Chicago District Office (CHI-DO)
9/18/2014
64LBJ99GLUCOCORTICOID N.E.C.
118NOT LISTED
Chicago District Office (CHI-DO)
8/6/2013
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
New York District Office (NYK-DO)
3/1/2011
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
New Orleans District Office (NOL-DO)
3/1/2011
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
New Orleans District Office (NOL-DO)
3/1/2011
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
New Orleans District Office (NOL-DO)
10/1/2003
62GPA99ANTI-INFLAMMATORY N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
10/1/2003
62UBB99ANTI-TUSSIVE/COLD N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
10/1/2003
62UBB99ANTI-TUSSIVE/COLD N.E.C.
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is SanUp's FDA import refusal history?

SanUp (FEI: 3004127824) has 9 FDA import refusal record(s) in our database, spanning from 10/1/2003 to 9/22/2014.

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. SanUp's FEI number is 3004127824.

What types of violations has SanUp received?

SanUp 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 SanUp come from?

All FDA import refusal data for SanUp 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.