The Cosmetic Republic S.L.
⚠️ Moderate Risk
FEI: 3007510281 • Barcelona, Barcelona • SPAIN
FEI Number
3007510281
Location
Barcelona, Barcelona
Country
SPAINAddress
Bj 1, Calle Mendez Nunez 3, Barcelona, 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
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2013 | 53EA99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 474COSMETLBLG | Philadelphia District Office (PHI-DO) |
| 7/31/2013 | 95RHLLASER THERAPY PRODUCT | Philadelphia District Office (PHI-DO) | |
| 7/31/2013 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is The Cosmetic Republic S.L.'s FDA import refusal history?
The Cosmetic Republic S.L. (FEI: 3007510281) has 3 FDA import refusal record(s) in our database, spanning from 7/31/2013 to 7/31/2013.
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. The Cosmetic Republic S.L.'s FEI number is 3007510281.
What types of violations has The Cosmetic Republic S.L. received?
The Cosmetic Republic S.L. 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 The Cosmetic Republic S.L. come from?
All FDA import refusal data for The Cosmetic Republic 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.