Ziaja Ltd. Zaklad Produkcji Lekaw Sp Zoo
⚠️ Moderate Risk
FEI: 3008260001 • Gdansk, Pomorskie • POLAND
FEI Number
3008260001
Location
Gdansk, Pomorskie
Country
POLANDAddress
Ul. Jesienna 9, , Gdansk, Pomorskie, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/12/2025 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/12/2025 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 4/11/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 7/13/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/13/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/13/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/13/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/5/2012 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Ziaja Ltd. Zaklad Produkcji Lekaw Sp Zoo's FDA import refusal history?
Ziaja Ltd. Zaklad Produkcji Lekaw Sp Zoo (FEI: 3008260001) has 8 FDA import refusal record(s) in our database, spanning from 7/5/2012 to 9/12/2025.
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. Ziaja Ltd. Zaklad Produkcji Lekaw Sp Zoo's FEI number is 3008260001.
What types of violations has Ziaja Ltd. Zaklad Produkcji Lekaw Sp Zoo received?
Ziaja Ltd. Zaklad Produkcji Lekaw Sp Zoo has been cited for 6 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 Ziaja Ltd. Zaklad Produkcji Lekaw Sp Zoo come from?
All FDA import refusal data for Ziaja Ltd. Zaklad Produkcji Lekaw Sp Zoo 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.