Bie-Dro C. Nuyken Kg
⚠️ Moderate Risk
FEI: 3008885878 • Bielefeld, North Rhine-Westphalia • GERMANY
FEI Number
3008885878
Location
Bielefeld, North Rhine-Westphalia
Country
GERMANYAddress
Industriestr. 38, , Bielefeld, North Rhine-Westphalia, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/18/2012 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 65LAJ11TITANIUM DIOXIDE (PROTECTANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 65LAJ11TITANIUM DIOXIDE (PROTECTANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 62WBJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 62WCJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 62WCJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 62WCJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 62WCJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 62WBJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 62WCJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 62WCR17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 62WCJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) | |
| 3/5/2012 | 62WCJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Bie-Dro C. Nuyken Kg's FDA import refusal history?
Bie-Dro C. Nuyken Kg (FEI: 3008885878) has 13 FDA import refusal record(s) in our database, spanning from 3/5/2012 to 4/18/2012.
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. Bie-Dro C. Nuyken Kg's FEI number is 3008885878.
What types of violations has Bie-Dro C. Nuyken Kg received?
Bie-Dro C. Nuyken Kg has been cited for 11 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 Bie-Dro C. Nuyken Kg come from?
All FDA import refusal data for Bie-Dro C. Nuyken 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.