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Mann & Schroeder Gmbh

⚠️ Moderate Risk

FEI: 3002652064 • Siegelsbach, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3002652064

📍

Location

Siegelsbach, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Bahnhofstr. 14, , Siegelsbach, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

37.8
LowModerateHighCritical

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

Statistics

20
Total Refusals
5
Unique Violations
12/23/2011
Latest Refusal
1/3/2008
Earliest Refusal

Score Breakdown

Violation Severity
45.1×40%
Refusal Volume
49.0×30%
Recency
0.0×20%
Frequency
50.3×10%
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

47316×

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.

4714×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

1973×

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).

1182×

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).

Refusal History

DateProductViolationsDivision
12/23/2011
53BD99OTHER BATH PREPARATIONS, N.E.C.
473LABELING
New York District Office (NYK-DO)
12/23/2011
53BD99OTHER BATH PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
New York District Office (NYK-DO)
12/23/2011
53BD99OTHER BATH PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
New York District Office (NYK-DO)
12/23/2011
53BD99OTHER BATH PREPARATIONS, N.E.C.
197COSM COLOR
471CSTIC LBLG
473LABELING
New York District Office (NYK-DO)
12/23/2011
53BD02BUBBLE BATHS (BATH PREPARATIONS)
197COSM COLOR
471CSTIC LBLG
473LABELING
New York District Office (NYK-DO)
3/30/2011
53BD99OTHER BATH PREPARATIONS, N.E.C.
197COSM COLOR
New York District Office (NYK-DO)
4/15/2010
53BD99OTHER BATH PREPARATIONS, N.E.C.
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/23/2009
53BD99OTHER BATH PREPARATIONS, N.E.C.
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
9/12/2008
53BD99OTHER BATH PREPARATIONS, N.E.C.
475COSMETLBLG
New York District Office (NYK-DO)
9/12/2008
53BD99OTHER BATH PREPARATIONS, N.E.C.
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
9/12/2008
53BD99OTHER BATH PREPARATIONS, N.E.C.
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
9/12/2008
53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
9/12/2008
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
9/12/2008
53BD99OTHER BATH PREPARATIONS, N.E.C.
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
9/12/2008
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
New York District Office (NYK-DO)
9/12/2008
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
New York District Office (NYK-DO)
9/12/2008
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
New York District Office (NYK-DO)
9/12/2008
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
New York District Office (NYK-DO)
1/3/2008
62SML99ANTI-SEBORRHEIC N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
1/3/2008
62GDL99ANTI-INFLAMMATORY N.E.C.
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Mann & Schroeder Gmbh's FDA import refusal history?

Mann & Schroeder Gmbh (FEI: 3002652064) has 20 FDA import refusal record(s) in our database, spanning from 1/3/2008 to 12/23/2011.

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. Mann & Schroeder Gmbh's FEI number is 3002652064.

What types of violations has Mann & Schroeder Gmbh received?

Mann & Schroeder Gmbh has been cited for 5 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 Mann & Schroeder Gmbh come from?

All FDA import refusal data for Mann & Schroeder 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.