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H Cosmetiques Ci

⚠️ Moderate Risk

FEI: 3011278730 • Milan • ITALY

FEI

FEI Number

3011278730

📍

Location

Milan

🇮🇹

Country

ITALY
🏢

Address

C/O Cromm International Srlcorso Magenta, , Milan, , Italy

Moderate Risk

FDA Import Risk Assessment

26.8
LowModerateHighCritical

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

Statistics

3
Total Refusals
6
Unique Violations
9/11/2017
Latest Refusal
9/6/2017
Earliest Refusal

Score Breakdown

Violation Severity
42.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3333×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3352×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

35002×

RXLABEL

The labeling fails to bear, at a minimum, the symbol "RX Only".

822×

RX LEGEND

The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
9/11/2017
64LDJ03BETAMETHASONE (GLUCOCORTICOID)
333LACKS FIRM
335LACKS N/C
3500RXLABEL
472NO ENGLISH
82RX LEGEND
Division of Northeast Imports (DNEI)
9/7/2017
64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID)
333LACKS FIRM
335LACKS N/C
3500RXLABEL
Division of Northeast Imports (DNEI)
9/6/2017
64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID)
223FALSE
333LACKS FIRM
82RX LEGEND
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is H Cosmetiques Ci's FDA import refusal history?

H Cosmetiques Ci (FEI: 3011278730) has 3 FDA import refusal record(s) in our database, spanning from 9/6/2017 to 9/11/2017.

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. H Cosmetiques Ci's FEI number is 3011278730.

What types of violations has H Cosmetiques Ci received?

H Cosmetiques Ci 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 H Cosmetiques Ci come from?

All FDA import refusal data for H Cosmetiques Ci 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.