Sasa Cosmetics ACS Ltd
⚠️ High Risk
FEI: 3011441949 • Giv'At Oz, Golan Heights • ISRAEL
FEI Number
3011441949
Location
Giv'At Oz, Golan Heights
Country
ISRAELAddress
Industrial Zone Benei Yehuda, Moshavyo Av, Giv'At Oz, Golan Heights, Israel
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2021 | 66PBK05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Southeast Imports (DSEI) | |
| 2/16/2021 | 66PBY16OCTOCRYLENE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/16/2021 | 66PBY16OCTOCRYLENE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/16/2021 | 66PBY16OCTOCRYLENE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2020 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2020 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2020 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2020 | 66PCY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2020 | 66PCY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2019 | 66PBJ14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 66PBJ14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 66PBJ14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Sasa Cosmetics ACS Ltd's FDA import refusal history?
Sasa Cosmetics ACS Ltd (FEI: 3011441949) has 12 FDA import refusal record(s) in our database, spanning from 12/3/2019 to 2/19/2021.
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. Sasa Cosmetics ACS Ltd's FEI number is 3011441949.
What types of violations has Sasa Cosmetics ACS Ltd received?
Sasa Cosmetics ACS Ltd has been cited for 4 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 Sasa Cosmetics ACS Ltd come from?
All FDA import refusal data for Sasa Cosmetics ACS 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.