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Pureneige Sarl

⚠️ Moderate Risk

FEI: 3004596364 • Le Mont Sur Lau • SWITZERLAND

FEI

FEI Number

3004596364

📍

Location

Le Mont Sur Lau

🇨🇭
🏢

Address

Chemin De Bellevue 5, , Le Mont Sur Lau, , Switzerland

Moderate Risk

FDA Import Risk Assessment

30.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
4
Unique Violations
8/30/2004
Latest Refusal
8/23/2004
Earliest Refusal

Score Breakdown

Violation Severity
47.5×40%
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

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.

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.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

4881×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
8/30/2004
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
475COSMETLBLG
New Orleans District Office (NOL-DO)
8/30/2004
53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New Orleans District Office (NOL-DO)
8/23/2004
53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
488HEALTH C
New Orleans District Office (NOL-DO)
8/23/2004
65LBL11TITANIUM DIOXIDE (PROTECTANT)
483DRUG NAME
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pureneige Sarl's FDA import refusal history?

Pureneige Sarl (FEI: 3004596364) has 4 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 8/30/2004.

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. Pureneige Sarl's FEI number is 3004596364.

What types of violations has Pureneige Sarl received?

Pureneige Sarl 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 Pureneige Sarl come from?

All FDA import refusal data for Pureneige Sarl 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.