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Bielenda Kosmetyki Natural Sp Zo

⚠️ Moderate Risk

FEI: 3005425531 • Liszki, Malopolskie • POLAND

FEI

FEI Number

3005425531

📍

Location

Liszki, Malopolskie

🇵🇱

Country

POLAND
🏢

Address

Cholerzyn 215, , Liszki, Malopolskie, Poland

Moderate Risk

FDA Import Risk Assessment

43.1
LowModerateHighCritical

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

Statistics

33
Total Refusals
5
Unique Violations
7/18/2013
Latest Refusal
7/17/2013
Earliest Refusal

Score Breakdown

Violation Severity
40.2×40%
Refusal Volume
56.7×30%
Recency
0.0×20%
Frequency
100.0×10%
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

47526×

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.

47117×

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.

4732×

LABELING

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

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
7/18/2013
66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Northeast Imports (DNEI)
7/17/2013
53LC07NIGHT (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC07NIGHT (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC07NIGHT (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53CC04EYE LOTION (EYE MAKEUP PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC07NIGHT (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC07NIGHT (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC07NIGHT (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC07NIGHT (SKIN CARE PREPARATIONS)
471CSTIC LBLG
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Division of Northeast Imports (DNEI)
7/17/2013
53CC04EYE LOTION (EYE MAKEUP PREPARATIONS)
471CSTIC LBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC07NIGHT (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC07NIGHT (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Division of Northeast Imports (DNEI)
7/17/2013
53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Bielenda Kosmetyki Natural Sp Zo's FDA import refusal history?

Bielenda Kosmetyki Natural Sp Zo (FEI: 3005425531) has 33 FDA import refusal record(s) in our database, spanning from 7/17/2013 to 7/18/2013.

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. Bielenda Kosmetyki Natural Sp Zo's FEI number is 3005425531.

What types of violations has Bielenda Kosmetyki Natural Sp Zo received?

Bielenda Kosmetyki Natural Sp Zo 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 Bielenda Kosmetyki Natural Sp Zo come from?

All FDA import refusal data for Bielenda Kosmetyki Natural Sp Zo 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.