Columbia Line S.L.
⚠️ Moderate Risk
FEI: 3004174859 • Valencia, Valencia • SPAIN
FEI Number
3004174859
Location
Valencia, Valencia
Country
SPAINAddress
Calle Doctor Carlos Caballer Lantry 3, Bajo, Valencia, Valencia, 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
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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.
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 |
|---|---|---|---|
| 3/4/2005 | 65LBJ99PROTECTANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/4/2005 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 3/4/2005 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 198COLOR LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Columbia Line S.L.'s FDA import refusal history?
Columbia Line S.L. (FEI: 3004174859) has 3 FDA import refusal record(s) in our database, spanning from 3/4/2005 to 3/4/2005.
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. Columbia Line S.L.'s FEI number is 3004174859.
What types of violations has Columbia Line S.L. received?
Columbia Line S.L. has been cited for 3 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 Columbia Line S.L. come from?
All FDA import refusal data for Columbia Line 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.