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Schupp Gmbh & Company

⚠️ Moderate Risk

FEI: 1000174578 • Freudenstadt, Baden-Wurttemberg • GERMANY

FEI

FEI Number

1000174578

📍

Location

Freudenstadt, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Postfach 840, , Freudenstadt, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

37.3
LowModerateHighCritical

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

Statistics

11
Total Refusals
4
Unique Violations
12/31/2015
Latest Refusal
2/22/2006
Earliest Refusal

Score Breakdown

Violation Severity
60.4×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
11.2×10%
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

1978×

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).

4738×

LABELING

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

4758×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
12/31/2015
53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
197COSM COLOR
473LABELING
475COSMETLBLG
Seattle District Office (SEA-DO)
12/31/2015
53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
197COSM COLOR
473LABELING
475COSMETLBLG
Seattle District Office (SEA-DO)
12/31/2015
53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
197COSM COLOR
473LABELING
475COSMETLBLG
Seattle District Office (SEA-DO)
12/31/2015
53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
197COSM COLOR
473LABELING
475COSMETLBLG
Seattle District Office (SEA-DO)
12/31/2015
53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
197COSM COLOR
473LABELING
475COSMETLBLG
Seattle District Office (SEA-DO)
12/31/2015
53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
197COSM COLOR
473LABELING
475COSMETLBLG
Seattle District Office (SEA-DO)
12/31/2015
53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
197COSM COLOR
473LABELING
475COSMETLBLG
Seattle District Office (SEA-DO)
12/31/2015
53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
197COSM COLOR
473LABELING
475COSMETLBLG
Seattle District Office (SEA-DO)
2/22/2006
53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
75UNAPPROVED
Philadelphia District Office (PHI-DO)
2/22/2006
53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
75UNAPPROVED
Philadelphia District Office (PHI-DO)
2/22/2006
53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Schupp Gmbh & Company's FDA import refusal history?

Schupp Gmbh & Company (FEI: 1000174578) has 11 FDA import refusal record(s) in our database, spanning from 2/22/2006 to 12/31/2015.

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. Schupp Gmbh & Company's FEI number is 1000174578.

What types of violations has Schupp Gmbh & Company received?

Schupp Gmbh & Company has been cited for 4 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 Schupp Gmbh & Company come from?

All FDA import refusal data for Schupp Gmbh & Company 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.