Nevada Zona Libre Sa
⚠️ Moderate Risk
FEI: 3010681452 • Zona Libre Republica De • PANAMA
FEI Number
3010681452
Location
Zona Libre Republica De
Country
PANAMAAddress
Calle 15 Santa Isabel Local, , Zona Libre Republica De, , Panama
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 3/11/2014 | 53JG01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Southwest Import District Office (SWI-DO) | |
| 3/11/2014 | 53JG01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Nevada Zona Libre Sa's FDA import refusal history?
Nevada Zona Libre Sa (FEI: 3010681452) has 2 FDA import refusal record(s) in our database, spanning from 3/11/2014 to 3/11/2014.
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. Nevada Zona Libre Sa's FEI number is 3010681452.
What types of violations has Nevada Zona Libre Sa received?
Nevada Zona Libre Sa 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 Nevada Zona Libre Sa come from?
All FDA import refusal data for Nevada Zona Libre 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.