Dax Cosmetics Sp Zo.O
⚠️ Moderate Risk
FEI: 3004989973 • Wiazowna, Mazowieckie • POLAND
FEI Number
3004989973
Location
Wiazowna, Mazowieckie
Country
POLANDAddress
Ul. Spacerowa 18, , Wiazowna, Mazowieckie, Poland
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/8/2023 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 10/22/2007 | 53JC01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Dax Cosmetics Sp Zo.O's FDA import refusal history?
Dax Cosmetics Sp Zo.O (FEI: 3004989973) has 18 FDA import refusal record(s) in our database, spanning from 10/22/2007 to 11/8/2023.
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. Dax Cosmetics Sp Zo.O's FEI number is 3004989973.
What types of violations has Dax Cosmetics Sp Zo.O received?
Dax Cosmetics Sp Zo.O has been cited for 7 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 Dax Cosmetics Sp Zo.O come from?
All FDA import refusal data for Dax Cosmetics Sp Zo.O 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.