ImportRefusal LogoImportRefusal

Bt Professionalmake Up Gmbh

⚠️ Moderate Risk

FEI: 3003070431 • Berlin, Berlin • GERMANY

FEI

FEI Number

3003070431

📍

Location

Berlin, Berlin

🇩🇪

Country

GERMANY
🏢

Address

Olivaer Platz 2, , Berlin, Berlin, Germany

Moderate Risk

FDA Import Risk Assessment

28.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
6/22/2004
Latest Refusal
10/16/2003
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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).

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

5081×

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.

Refusal History

DateProductViolationsDivision
6/22/2004
53CD99OTHER EYE MAKEUP PREPARATIONS, N.E.C.
475COSMETLBLG
New Orleans District Office (NOL-DO)
10/16/2003
73BWINEEDLE, ACUPUNCTURE
118NOT LISTED
508NO 510(K)
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Bt Professionalmake Up Gmbh's FDA import refusal history?

Bt Professionalmake Up Gmbh (FEI: 3003070431) has 2 FDA import refusal record(s) in our database, spanning from 10/16/2003 to 6/22/2004.

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. Bt Professionalmake Up Gmbh's FEI number is 3003070431.

What types of violations has Bt Professionalmake Up Gmbh received?

Bt Professionalmake Up Gmbh 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 Bt Professionalmake Up Gmbh come from?

All FDA import refusal data for Bt Professionalmake Up Gmbh 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.