Sepai Beauticeutical Division, S.L.
⚠️ Moderate Risk
FEI: 3008524403 • Barcelona • SPAIN
FEI Number
3008524403
Location
Barcelona
Country
SPAINAddress
Piso 4, Calle Beethoven 15, 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/26/2015 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Division of Northern Border Imports (DNBI) |
| 2/26/2015 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 473LABELING | Division of Northern Border Imports (DNBI) |
| 2/26/2015 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 473LABELING | Division of Northern Border Imports (DNBI) |
| 2/26/2015 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 473LABELING | Division of Northern Border Imports (DNBI) |
| 2/26/2015 | 65GBY99PIGMENTATION AGENT N.E.C. | 473LABELING | Division of Northern Border Imports (DNBI) |
| 2/26/2015 | 65GBY99PIGMENTATION AGENT N.E.C. | 473LABELING | Division of Northern Border Imports (DNBI) |
| 2/26/2015 | 65GBY99PIGMENTATION AGENT N.E.C. | 473LABELING | Division of Northern Border Imports (DNBI) |
| 2/26/2015 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 2/26/2015 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 2/26/2015 | 66PBS99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Sepai Beauticeutical Division, S.L.'s FDA import refusal history?
Sepai Beauticeutical Division, S.L. (FEI: 3008524403) has 10 FDA import refusal record(s) in our database, spanning from 2/26/2015 to 2/26/2015.
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. Sepai Beauticeutical Division, S.L.'s FEI number is 3008524403.
What types of violations has Sepai Beauticeutical Division, S.L. received?
Sepai Beauticeutical Division, S.L. has been cited for 2 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 Sepai Beauticeutical Division, S.L. come from?
All FDA import refusal data for Sepai Beauticeutical Division, 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.