Rovi Cosmetics Intern. Gmbh

⚠️ Moderate Risk

FEI: 3005880964 • Schluchtern, Hesse • GERMANY

FEI

FEI Number

3005880964

📍

Location

Schluchtern, Hesse

🇩🇪

Country

GERMANY

🏢

Address

Breitwiesenstr. 1, , Schluchtern, Hesse, Germany

Moderate Risk

FDA Import Risk Assessment

29.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

4/26/2012

Latest Refusal

3/26/2008

Earliest Refusal

Score Breakdown

Violation Severity

44.8×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

17.1×10%

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

4746×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

4756×

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.

1185×

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).

4712×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

3121×

FILTH

The cosmetic appears to consist in whole or in part of any filthy, putrid, or decomposed substance.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

Date	Product	Violations	Division
4/26/2012	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	312FILTH 471CSTIC LBLG 475COSMETLBLG	New Orleans District Office (NOL-DO)
3/26/2008	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
3/26/2008	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	118NOT LISTED 474COSMETLBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
3/26/2008	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	118NOT LISTED 474COSMETLBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
3/26/2008	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	118NOT LISTED 474COSMETLBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
3/26/2008	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	118NOT LISTED 474COSMETLBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
3/26/2008	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	118NOT LISTED 474COSMETLBLG	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Rovi Cosmetics Intern. Gmbh's FDA import refusal history?

Rovi Cosmetics Intern. Gmbh (FEI: 3005880964) has 7 FDA import refusal record(s) in our database, spanning from 3/26/2008 to 4/26/2012.

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. Rovi Cosmetics Intern. Gmbh's FEI number is 3005880964.

What types of violations has Rovi Cosmetics Intern. Gmbh received?

Rovi Cosmetics Intern. Gmbh has been cited for 6 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 Rovi Cosmetics Intern. Gmbh come from?

All FDA import refusal data for Rovi Cosmetics Intern. 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.