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FREMAR BV

⚠️ Moderate Risk

FEI: 3014268270 • Berkel En Rodenrijs, Zuid-Holland • NETHERLANDS

FEI

FEI Number

3014268270

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Location

Berkel En Rodenrijs, Zuid-Holland

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🏢

Address

Planetenweg 43, , Berkel En Rodenrijs, Zuid-Holland, Netherlands

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/30/2018
Latest Refusal
3/30/2018
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

21201×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
3/30/2018
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2120UNSFDIETSP
473LABELING
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FREMAR BV's FDA import refusal history?

FREMAR BV (FEI: 3014268270) has 1 FDA import refusal record(s) in our database, spanning from 3/30/2018 to 3/30/2018.

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. FREMAR BV's FEI number is 3014268270.

What types of violations has FREMAR BV received?

FREMAR BV 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 FREMAR BV come from?

All FDA import refusal data for FREMAR BV 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.