Inspira Cosmetics Gmbh

⚠️ Moderate Risk

FEI: 3010323884 • Aachen, North Rhine-Westphalia • GERMANY

FEI

FEI Number

3010323884

📍

Location

Aachen, North Rhine-Westphalia

🇩🇪

Country

GERMANY

🏢

Address

Hirzenrott 13, , Aachen, North Rhine-Westphalia, Germany

Moderate Risk

FDA Import Risk Assessment

46.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/19/2017

Latest Refusal

10/22/2013

Earliest Refusal

Score Breakdown

Violation Severity

87.1×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

19.1×10%

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

3104×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

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).

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

Refusal History

Date	Product	Violations	Division
6/19/2017	53LH99OTHER SKIN CARE PREPARATIONS, N.E.C.	310POISONOUS	Division of Northern Border Imports (DNBI)
6/19/2017	53LH99OTHER SKIN CARE PREPARATIONS, N.E.C.	310POISONOUS	Division of Northern Border Imports (DNBI)
6/19/2017	53LH99OTHER SKIN CARE PREPARATIONS, N.E.C.	310POISONOUS	Division of Northern Border Imports (DNBI)
1/24/2017	53LH99OTHER SKIN CARE PREPARATIONS, N.E.C.	310POISONOUS	New York District Office (NYK-DO)
11/22/2016	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Philadelphia District Office (PHI-DO)
10/22/2013	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	178COL ADDED	Minneapolis District Office (MIN-DO)
10/22/2013	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	11UNSAFE COL	Minneapolis District Office (MIN-DO)

Frequently Asked Questions

What is Inspira Cosmetics Gmbh's FDA import refusal history?

Inspira Cosmetics Gmbh (FEI: 3010323884) has 7 FDA import refusal record(s) in our database, spanning from 10/22/2013 to 6/19/2017.

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. Inspira Cosmetics Gmbh's FEI number is 3010323884.

What types of violations has Inspira Cosmetics Gmbh received?

Inspira Cosmetics Gmbh has been cited for 4 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 Inspira Cosmetics Gmbh come from?

All FDA import refusal data for Inspira 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.