Sano International Ltd
⚠️ Moderate Risk
FEI: 3008905981 • Hod Hasharon • ISRAEL
FEI Number
3008905981
Location
Hod Hasharon
Country
ISRAELAddress
Neve Neeman Industrial Zone, , Hod Hasharon, , Israel
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.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/4/2023 | 76EFWTOOTHBRUSH, MANUAL | Division of Northeast Imports (DNEI) | |
| 5/15/2015 | 65L99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/2/2012 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 3/2/2012 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 3/2/2012 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 3/2/2012 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 3/2/2012 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) | |
| 3/2/2012 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) | |
| 3/2/2012 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 3/2/2012 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 3/2/2012 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 3/2/2012 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sano International Ltd's FDA import refusal history?
Sano International Ltd (FEI: 3008905981) has 12 FDA import refusal record(s) in our database, spanning from 3/2/2012 to 5/4/2023.
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 3008905981.
What types of violations has Sano International Ltd received?
Sano International Ltd has been cited for 6 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.