Italian Group S.R.L.

⚠️ Moderate Risk

FEI: 3004106325 • Brescia, BS • ITALY

FEI

FEI Number

3004106325

📍

Location

Brescia, BS

🇮🇹

Country

ITALY

🏢

Address

Via Aldo Moro N 13, , Brescia, BS, Italy

Moderate Risk

FDA Import Risk Assessment

41.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/31/2006

Latest Refusal

4/6/2006

Earliest Refusal

Score Breakdown

Violation Severity

68.6×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

50.0×10%

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

Violation Summary

1974×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

4711×

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.

4741×

COSMETLBLG

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

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.

Refusal History

Date	Product	Violations	Division
10/31/2006	53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR	Southwest Import District Office (SWI-DO)
10/31/2006	53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR	Southwest Import District Office (SWI-DO)
10/31/2006	53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR	Southwest Import District Office (SWI-DO)
10/31/2006	53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR	Southwest Import District Office (SWI-DO)
4/6/2006	53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 474COSMETLBLG 475COSMETLBLG	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Italian Group S.R.L.'s FDA import refusal history?

Italian Group S.R.L. (FEI: 3004106325) has 5 FDA import refusal record(s) in our database, spanning from 4/6/2006 to 10/31/2006.

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. Italian Group S.R.L.'s FEI number is 3004106325.

What types of violations has Italian Group S.R.L. received?

Italian Group S.R.L. 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 Italian Group S.R.L. come from?

All FDA import refusal data for Italian Group S.R.L. 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.