Purebeau New Cosmetics Gmbh

⚠️ Moderate Risk

FEI: 3007861944 • Berlin, Berlin • GERMANY

FEI

FEI Number

3007861944

📍

Location

Berlin, Berlin

🇩🇪

Country

GERMANY

🏢

Address

Mozartstr. 12, , Berlin, Berlin, Germany

Moderate Risk

FDA Import Risk Assessment

48.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/23/2023

Latest Refusal

6/27/2017

Earliest Refusal

Score Breakdown

Violation Severity

49.4×40%

Refusal Volume

52.4×30%

Recency

42.4×20%

Frequency

44.1×10%

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

Violation Summary

19813×

COLOR LBLG

The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.

34110×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5089×

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

Date	Product	Violations	Division
2/23/2023	53YY04TATTOO INK	508NO 510(K)	Division of Northeast Imports (DNEI)
6/22/2021	53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.	508NO 510(K)	Division of Southeast Imports (DSEI)
6/27/2017	79OABSYSTEM ABLATIONS, LOW ENERGY DIRECT CURRENT AND ACCESSORIES	341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
6/27/2017	79OABSYSTEM ABLATIONS, LOW ENERGY DIRECT CURRENT AND ACCESSORIES	341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
6/27/2017	79OABSYSTEM ABLATIONS, LOW ENERGY DIRECT CURRENT AND ACCESSORIES	341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
6/27/2017	79OABSYSTEM ABLATIONS, LOW ENERGY DIRECT CURRENT AND ACCESSORIES	341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
6/27/2017	79OABSYSTEM ABLATIONS, LOW ENERGY DIRECT CURRENT AND ACCESSORIES	341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
6/27/2017	79OABSYSTEM ABLATIONS, LOW ENERGY DIRECT CURRENT AND ACCESSORIES	341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
6/27/2017	79OABSYSTEM ABLATIONS, LOW ENERGY DIRECT CURRENT AND ACCESSORIES	341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
6/27/2017	78FHQHOLDER, NEEDLE	341REGISTERED	Division of Northern Border Imports (DNBI)
6/27/2017	79OABSYSTEM ABLATIONS, LOW ENERGY DIRECT CURRENT AND ACCESSORIES	341REGISTERED	Division of Northern Border Imports (DNBI)
6/27/2017	79OABSYSTEM ABLATIONS, LOW ENERGY DIRECT CURRENT AND ACCESSORIES	341REGISTERED	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2017	53YY04TATTOO INK	198COLOR LBLG	Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Purebeau New Cosmetics Gmbh's FDA import refusal history?

Purebeau New Cosmetics Gmbh (FEI: 3007861944) has 25 FDA import refusal record(s) in our database, spanning from 6/27/2017 to 2/23/2023.

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. Purebeau New Cosmetics Gmbh's FEI number is 3007861944.

What types of violations has Purebeau New Cosmetics Gmbh received?

Purebeau New Cosmetics 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 Purebeau New Cosmetics Gmbh come from?

All FDA import refusal data for Purebeau New Cosmetics 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.