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ROHEN LAB

⚠️ Moderate Risk

FEI: 3027141461 • Barcelona, Barcelona • SPAIN

FEI

FEI Number

3027141461

📍

Location

Barcelona, Barcelona

🇪🇸

Country

SPAIN
🏢

Address

Avinguda Diagonal 539 2 Izq., , Barcelona, Barcelona, Spain

Moderate Risk

FDA Import Risk Assessment

35.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/1/2023
Latest Refusal
12/1/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
57.2×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
12/1/2023
65LBL11TITANIUM DIOXIDE (PROTECTANT)
3280FRNMFGREG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is ROHEN LAB's FDA import refusal history?

ROHEN LAB (FEI: 3027141461) has 1 FDA import refusal record(s) in our database, spanning from 12/1/2023 to 12/1/2023.

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. ROHEN LAB's FEI number is 3027141461.

What types of violations has ROHEN LAB received?

ROHEN LAB 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 ROHEN LAB come from?

All FDA import refusal data for ROHEN LAB 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.