Laboratorio-Droguer. Y Farm.Morazan
⚠️ Moderate Risk
FEI: 3003364511 • Cuscatlan • EL SALVADOR
FEI Number
3003364511
Location
Cuscatlan
Country
EL SALVADORAddress
Calle 6 Zona Industrial Santa Elena, , Cuscatlan, , El Salvador
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 |
|---|---|---|---|
| 1/7/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Florida District Office (FLA-DO) |
| 6/17/2009 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Florida District Office (FLA-DO) |
| 12/20/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Laboratorio-Droguer. Y Farm.Morazan's FDA import refusal history?
Laboratorio-Droguer. Y Farm.Morazan (FEI: 3003364511) has 3 FDA import refusal record(s) in our database, spanning from 12/20/2005 to 1/7/2011.
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-Droguer. Y Farm.Morazan's FEI number is 3003364511.
What types of violations has Laboratorio-Droguer. Y Farm.Morazan received?
Laboratorio-Droguer. Y Farm.Morazan 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-Droguer. Y Farm.Morazan come from?
All FDA import refusal data for Laboratorio-Droguer. Y Farm.Morazan 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.