Laboratorios Spaisons Ltda
⚠️ Moderate Risk
FEI: 3003142018 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3003142018
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Diagonal 3d #4470 / 72, , Bogota, Cundinamarca, 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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/10/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Florida District Office (FLA-DO) | |
| 6/10/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Florida District Office (FLA-DO) | |
| 6/10/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2005 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/17/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/17/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorios Spaisons Ltda's FDA import refusal history?
Laboratorios Spaisons Ltda (FEI: 3003142018) has 11 FDA import refusal record(s) in our database, spanning from 5/17/2005 to 6/10/2005.
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. Laboratorios Spaisons Ltda's FEI number is 3003142018.
What types of violations has Laboratorios Spaisons Ltda received?
Laboratorios Spaisons Ltda 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 Laboratorios Spaisons Ltda come from?
All FDA import refusal data for Laboratorios Spaisons Ltda 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.