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Iwk Verpackungstechnik Gmbh

⚠️ Moderate Risk

FEI: 1000413630 • Stutensee, Baden-Wurttemberg • GERMANY

FEI

FEI Number

1000413630

📍

Location

Stutensee, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Postfach 1151, Lorenzstr 6, Stutensee, Baden-Wurttemberg, Germany

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
6/9/2010
Latest Refusal
6/9/2010
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

1181×

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.

Refusal History

DateProductViolationsDivision
6/9/2010
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Iwk Verpackungstechnik Gmbh's FDA import refusal history?

Iwk Verpackungstechnik Gmbh (FEI: 1000413630) has 1 FDA import refusal record(s) in our database, spanning from 6/9/2010 to 6/9/2010.

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. Iwk Verpackungstechnik Gmbh's FEI number is 1000413630.

What types of violations has Iwk Verpackungstechnik Gmbh received?

Iwk Verpackungstechnik Gmbh 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 Iwk Verpackungstechnik Gmbh come from?

All FDA import refusal data for Iwk Verpackungstechnik Gmbh 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.