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Comimpex Handelsges Mbh & Co Kg

⚠️ Moderate Risk

FEI: 3006008670 • Seevetal, Lower Saxony • GERMANY

FEI

FEI Number

3006008670

📍

Location

Seevetal, Lower Saxony

🇩🇪

Country

GERMANY
🏢

Address

Schillerplatz 5, , Seevetal, Lower Saxony, Germany

Moderate Risk

FDA Import Risk Assessment

43.0
LowModerateHighCritical

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

Statistics

12
Total Refusals
3
Unique Violations
2/2/2011
Latest Refusal
6/23/2010
Earliest Refusal

Score Breakdown

Violation Severity
51.7×40%
Refusal Volume
41.3×30%
Recency
0.0×20%
Frequency
100.0×10%
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

47312×

LABELING

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

1188×

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).

1974×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

Refusal History

DateProductViolationsDivision
2/2/2011
62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
473LABELING
New York District Office (NYK-DO)
2/2/2011
62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
473LABELING
New York District Office (NYK-DO)
2/2/2011
62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
473LABELING
New York District Office (NYK-DO)
2/2/2011
62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
473LABELING
New York District Office (NYK-DO)
8/23/2010
62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
473LABELING
New York District Office (NYK-DO)
8/23/2010
62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
473LABELING
New York District Office (NYK-DO)
8/23/2010
62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
473LABELING
New York District Office (NYK-DO)
8/23/2010
62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
473LABELING
New York District Office (NYK-DO)
6/23/2010
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
473LABELING
New York District Office (NYK-DO)
6/23/2010
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
473LABELING
New York District Office (NYK-DO)
6/23/2010
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
473LABELING
New York District Office (NYK-DO)
6/23/2010
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
473LABELING
New York District Office (NYK-DO)

Frequently Asked Questions

What is Comimpex Handelsges Mbh & Co Kg's FDA import refusal history?

Comimpex Handelsges Mbh & Co Kg (FEI: 3006008670) has 12 FDA import refusal record(s) in our database, spanning from 6/23/2010 to 2/2/2011.

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. Comimpex Handelsges Mbh & Co Kg's FEI number is 3006008670.

What types of violations has Comimpex Handelsges Mbh & Co Kg received?

Comimpex Handelsges Mbh & Co Kg 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 Comimpex Handelsges Mbh & Co Kg come from?

All FDA import refusal data for Comimpex Handelsges Mbh & Co Kg 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.