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Phitoderm Magic Cosmetics

⚠️ Moderate Risk

FEI: 1000312705 • Rome, Rome • ITALY

FEI

FEI Number

1000312705

📍

Location

Rome, Rome

🇮🇹

Country

ITALY
🏢

Address

Via Fabio Conforto 12/14, , Rome, Rome, Italy

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/13/2008
Latest Refusal
6/13/2008
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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).

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.

Refusal History

DateProductViolationsDivision
6/13/2008
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
San Juan District Office (SJN-DO)
6/13/2008
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is Phitoderm Magic Cosmetics's FDA import refusal history?

Phitoderm Magic Cosmetics (FEI: 1000312705) has 2 FDA import refusal record(s) in our database, spanning from 6/13/2008 to 6/13/2008.

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. Phitoderm Magic Cosmetics's FEI number is 1000312705.

What types of violations has Phitoderm Magic Cosmetics received?

Phitoderm Magic Cosmetics has been cited for 2 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 Phitoderm Magic Cosmetics come from?

All FDA import refusal data for Phitoderm Magic Cosmetics 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.