Sano International Ltd
🚨 Critical Risk
FEI: 3008546324 • Hashron • ISRAEL
FEI Number
3008546324
Location
Hashron
Country
ISRAELAddress
Neve Neeman Po Box, , Hashron, , Israel
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe violations.
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
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 |
|---|---|---|---|
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/10/2025 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Sano International Ltd's FDA import refusal history?
Sano International Ltd (FEI: 3008546324) has 16 FDA import refusal record(s) in our database, spanning from 12/10/2025 to 12/10/2025.
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. Sano International Ltd's FEI number is 3008546324.
What types of violations has Sano International Ltd received?
Sano International Ltd has been cited for 1 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 Sano International Ltd come from?
All FDA import refusal data for Sano International Ltd 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.