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Hildegard Braukmann

⚠️ Moderate Risk

FEI: 3007887761 • Burgwedel, Niedersachsen • GERMANY

FEI

FEI Number

3007887761

📍

Location

Burgwedel, Niedersachsen

🇩🇪

Country

GERMANY
🏢

Address

Ehlbeek 16, , Burgwedel, Niedersachsen, Germany

Moderate Risk

FDA Import Risk Assessment

42.2
LowModerateHighCritical

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

Statistics

8
Total Refusals
5
Unique Violations
5/28/2013
Latest Refusal
11/5/2012
Earliest Refusal

Score Breakdown

Violation Severity
59.1×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

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).

4713×

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.

4752×

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.

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).

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

Refusal History

DateProductViolationsDivision
5/28/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
475COSMETLBLG
New Orleans District Office (NOL-DO)
5/28/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
New Orleans District Office (NOL-DO)
5/28/2013
53CD99OTHER EYE MAKEUP PREPARATIONS, N.E.C.
471CSTIC LBLG
New Orleans District Office (NOL-DO)
5/28/2013
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
197COSM COLOR
474COSMETLBLG
New Orleans District Office (NOL-DO)
5/28/2013
53CD06MASCARA (EYE MAKEUP PREPARATIONS)
197COSM COLOR
471CSTIC LBLG
New Orleans District Office (NOL-DO)
5/28/2013
53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
197COSM COLOR
New Orleans District Office (NOL-DO)
5/28/2013
53TK12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (PORCINE)
197COSM COLOR
New Orleans District Office (NOL-DO)
11/5/2012
65LBL99PROTECTANT N.E.C.
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Hildegard Braukmann's FDA import refusal history?

Hildegard Braukmann (FEI: 3007887761) has 8 FDA import refusal record(s) in our database, spanning from 11/5/2012 to 5/28/2013.

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. Hildegard Braukmann's FEI number is 3007887761.

What types of violations has Hildegard Braukmann received?

Hildegard Braukmann 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 Hildegard Braukmann come from?

All FDA import refusal data for Hildegard Braukmann 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.