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V.S.M. Geneesmiddelen

⚠️ Moderate Risk

FEI: 1000165472 • Alkmaar, Noord-holland • NETHERLANDS

FEI

FEI Number

1000165472

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Location

Alkmaar, Noord-holland

🇳🇱
🏢

Address

Berenkoog 35, , Alkmaar, Noord-holland, Netherlands

Moderate Risk

FDA Import Risk Assessment

34.1
LowModerateHighCritical

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

Statistics

6
Total Refusals
3
Unique Violations
6/8/2006
Latest Refusal
3/4/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
47.5×10%
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

1185×

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).

161×

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.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
6/8/2006
60LBA99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/8/2006
60LBA99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/8/2006
60LBA99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/8/2006
60LBA99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/8/2006
60LBA99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
3/4/2005
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is V.S.M. Geneesmiddelen's FDA import refusal history?

V.S.M. Geneesmiddelen (FEI: 1000165472) has 6 FDA import refusal record(s) in our database, spanning from 3/4/2005 to 6/8/2006.

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. V.S.M. Geneesmiddelen's FEI number is 1000165472.

What types of violations has V.S.M. Geneesmiddelen received?

V.S.M. Geneesmiddelen has been cited for 3 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 V.S.M. Geneesmiddelen come from?

All FDA import refusal data for V.S.M. Geneesmiddelen 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.