Zenith Medicosm, S.L.
⚠️ Moderate Risk
FEI: 3009064446 • Vallirana, Barcelona • SPAIN
FEI Number
3009064446
Location
Vallirana, Barcelona
Country
SPAINAddress
C/ Buenos Aires, 37, , Vallirana, Barcelona, Spain
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/8/2022 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | Division of Southeast Imports (DSEI) |
| 4/2/2013 | 66PCY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 4/2/2013 | 65LBY11TITANIUM DIOXIDE (PROTECTANT) | 473LABELING | San Juan District Office (SJN-DO) |
| 4/2/2013 | 65LBY11TITANIUM DIOXIDE (PROTECTANT) | 473LABELING | San Juan District Office (SJN-DO) |
| 4/2/2013 | 66PCY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 4/2/2013 | 66PCY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 4/2/2013 | 66PCY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 4/2/2013 | 66PCY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 4/2/2013 | 66PCY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Zenith Medicosm, S.L.'s FDA import refusal history?
Zenith Medicosm, S.L. (FEI: 3009064446) has 9 FDA import refusal record(s) in our database, spanning from 4/2/2013 to 6/8/2022.
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. Zenith Medicosm, S.L.'s FEI number is 3009064446.
What types of violations has Zenith Medicosm, S.L. received?
Zenith Medicosm, S.L. has been cited for 1 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 Zenith Medicosm, S.L. come from?
All FDA import refusal data for Zenith Medicosm, S.L. 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.