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CONDOMI ERFURT PRODUKTIONSGESELLSCHAFT MBH

⚠️ Moderate Risk

FEI: 3007307513 • Erfurt, Thuringia • GERMANY

FEI

FEI Number

3007307513

📍

Location

Erfurt, Thuringia

🇩🇪

Country

GERMANY
🏢

Address

Tiergartenstr. 2, , Erfurt, Thuringia, Germany

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

13
Total Refusals
3
Unique Violations
1/20/2012
Latest Refusal
10/19/2009
Earliest Refusal

Score Breakdown

Violation Severity
57.0×40%
Refusal Volume
42.5×30%
Recency
0.0×20%
Frequency
57.6×10%
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

11811×

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).

50810×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

32602×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
1/20/2012
85HISCONDOM
118NOT LISTED
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
3260NO ENGLISH
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
3260NO ENGLISH
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/19/2009
85HISCONDOM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is CONDOMI ERFURT PRODUKTIONSGESELLSCHAFT MBH's FDA import refusal history?

CONDOMI ERFURT PRODUKTIONSGESELLSCHAFT MBH (FEI: 3007307513) has 13 FDA import refusal record(s) in our database, spanning from 10/19/2009 to 1/20/2012.

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. CONDOMI ERFURT PRODUKTIONSGESELLSCHAFT MBH's FEI number is 3007307513.

What types of violations has CONDOMI ERFURT PRODUKTIONSGESELLSCHAFT MBH received?

CONDOMI ERFURT PRODUKTIONSGESELLSCHAFT MBH 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 CONDOMI ERFURT PRODUKTIONSGESELLSCHAFT MBH come from?

All FDA import refusal data for CONDOMI ERFURT PRODUKTIONSGESELLSCHAFT MBH 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.