Compania Barcelonesa De Iniciativas Sa
⚠️ Moderate Risk
FEI: 3003836629 • Barcelona, Barcelona • SPAIN
FEI Number
3003836629
Location
Barcelona, Barcelona
Country
SPAINAddress
Passeig de Gracia 98, , 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
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).
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 |
|---|---|---|---|
| 12/24/2002 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 12/24/2002 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 12/24/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Compania Barcelonesa De Iniciativas Sa's FDA import refusal history?
Compania Barcelonesa De Iniciativas Sa (FEI: 3003836629) has 3 FDA import refusal record(s) in our database, spanning from 12/24/2002 to 12/24/2002.
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. Compania Barcelonesa De Iniciativas Sa's FEI number is 3003836629.
What types of violations has Compania Barcelonesa De Iniciativas Sa received?
Compania Barcelonesa De Iniciativas Sa 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 Compania Barcelonesa De Iniciativas Sa come from?
All FDA import refusal data for Compania Barcelonesa De Iniciativas Sa 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.