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FORMA ITALIANA SPA

⚠️ Moderate Risk

FEI: 3012424941 • Lacchiarella, Milan • ITALY

FEI

FEI Number

3012424941

📍

Location

Lacchiarella, Milan

🇮🇹

Country

ITALY
🏢

Address

Via Cascina Nuova 1, , Lacchiarella, Milan, Italy

Moderate Risk

FDA Import Risk Assessment

30.9
LowModerateHighCritical

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

Statistics

4
Total Refusals
5
Unique Violations
12/17/2018
Latest Refusal
12/17/2018
Earliest Refusal

Score Breakdown

Violation Severity
47.9×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4714×

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.

4734×

LABELING

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

4744×

COSMETLBLG

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

4754×

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.

1973×

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).

Refusal History

DateProductViolationsDivision
12/17/2018
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
12/17/2018
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
12/17/2018
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
12/17/2018
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is FORMA ITALIANA SPA's FDA import refusal history?

FORMA ITALIANA SPA (FEI: 3012424941) has 4 FDA import refusal record(s) in our database, spanning from 12/17/2018 to 12/17/2018.

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. FORMA ITALIANA SPA's FEI number is 3012424941.

What types of violations has FORMA ITALIANA SPA received?

FORMA ITALIANA SPA has been cited for 5 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 FORMA ITALIANA SPA come from?

All FDA import refusal data for FORMA ITALIANA SPA 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.