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EMPWR Netherlands BV

✅ Low Risk

FEI: 3004661553 • Leerdam, Utrecht • NETHERLANDS

FEI

FEI Number

3004661553

📍

Location

Leerdam, Utrecht

🇳🇱
🏢

Address

Energieweg 22, , Leerdam, Utrecht, Netherlands

Low Risk

FDA Import Risk Assessment

23.1
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

3
Total Refusals
4
Unique Violations
12/12/2017
Latest Refusal
6/7/2011
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
4.6×10%
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

3212×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

33202×

TRANSFAT

The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].

4822×

NUTRIT LBL

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 fails to bear the required nutrition information.

4731×

LABELING

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

Refusal History

DateProductViolationsDivision
12/12/2017
07YHH99SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
473LABELING
Division of Southeast Imports (DSEI)
6/7/2011
41EDT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
321LACKS N/C
3320TRANSFAT
482NUTRIT LBL
New Orleans District Office (NOL-DO)
6/7/2011
41EDT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
321LACKS N/C
3320TRANSFAT
482NUTRIT LBL
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is EMPWR Netherlands BV's FDA import refusal history?

EMPWR Netherlands BV (FEI: 3004661553) has 3 FDA import refusal record(s) in our database, spanning from 6/7/2011 to 12/12/2017.

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. EMPWR Netherlands BV's FEI number is 3004661553.

What types of violations has EMPWR Netherlands BV received?

EMPWR Netherlands BV 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 EMPWR Netherlands BV come from?

All FDA import refusal data for EMPWR Netherlands 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.