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BIOCOSMETICS LABORATORIES S.L.

⚠️ Moderate Risk

FEI: 3034077225 • Las Rozas De Madrid, Madrid • SPAIN

FEI

FEI Number

3034077225

📍

Location

Las Rozas De Madrid, Madrid

🇪🇸

Country

SPAIN
🏢

Address

Calle Del Valle De Alcudia 3, , Las Rozas De Madrid, Madrid, Spain

Moderate Risk

FDA Import Risk Assessment

36.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/28/2025
Latest Refusal
1/28/2025
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
80.7×20%
Frequency
10.0×10%
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.

Refusal History

DateProductViolationsDivision
1/28/2025
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
471CSTIC LBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BIOCOSMETICS LABORATORIES S.L.'s FDA import refusal history?

BIOCOSMETICS LABORATORIES S.L. (FEI: 3034077225) has 1 FDA import refusal record(s) in our database, spanning from 1/28/2025 to 1/28/2025.

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. BIOCOSMETICS LABORATORIES S.L.'s FEI number is 3034077225.

What types of violations has BIOCOSMETICS LABORATORIES S.L. received?

BIOCOSMETICS LABORATORIES S.L. has been cited for 1 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 BIOCOSMETICS LABORATORIES S.L. come from?

All FDA import refusal data for BIOCOSMETICS LABORATORIES S.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.