Laboratorio De Cosmeticos Zande
⚠️ Moderate Risk
FEI: 3006362944 • Barranquilla • COLOMBIA
FEI Number
3006362944
Location
Barranquilla
Country
COLOMBIAAddress
Cl 42 4369, , Barranquilla, , Colombia
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2015 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | Florida District Office (FLA-DO) |
| 6/13/2012 | 53EC07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Florida District Office (FLA-DO) |
| 9/23/2010 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratorio De Cosmeticos Zande's FDA import refusal history?
Laboratorio De Cosmeticos Zande (FEI: 3006362944) has 3 FDA import refusal record(s) in our database, spanning from 9/23/2010 to 12/22/2015.
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. Laboratorio De Cosmeticos Zande's FEI number is 3006362944.
What types of violations has Laboratorio De Cosmeticos Zande received?
Laboratorio De Cosmeticos Zande 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 Laboratorio De Cosmeticos Zande come from?
All FDA import refusal data for Laboratorio De Cosmeticos Zande 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.