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Imres

⚠️ Moderate Risk

FEI: 3002820028 • Wezep Ac • NETHERLANDS

FEI

FEI Number

3002820028

📍

Location

Wezep Ac

🇳🇱
🏢

Address

Rondweg 13-15p.O. Box 138, , Wezep Ac, , Netherlands

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

4
Total Refusals
2
Unique Violations
10/26/2001
Latest Refusal
10/26/2001
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1184×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

164×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
10/26/2001
56YYY99ANTIBIOTIC N.E.C.
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)
10/26/2001
56YYY99ANTIBIOTIC N.E.C.
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)
10/26/2001
64NDY06FERROUS SULFATE (HEMATINIC)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)
10/26/2001
56YYY99ANTIBIOTIC N.E.C.
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Imres's FDA import refusal history?

Imres (FEI: 3002820028) has 4 FDA import refusal record(s) in our database, spanning from 10/26/2001 to 10/26/2001.

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. Imres's FEI number is 3002820028.

What types of violations has Imres received?

Imres 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 Imres come from?

All FDA import refusal data for Imres 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.