Shavit Natural Quality Product
⚠️ Moderate Risk
FEI: 3008179628 • Tel Aviv • ISRAEL
FEI Number
3008179628
Location
Tel Aviv
Country
ISRAELAddress
Pinchas Rozen 64, , Tel Aviv, , 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 5/9/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 5/9/2012 | 53EA01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Division of Northeast Imports (DNEI) | |
| 5/9/2012 | 53EA01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Division of Northeast Imports (DNEI) | |
| 5/9/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 5/9/2012 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 1/6/2012 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Shavit Natural Quality Product's FDA import refusal history?
Shavit Natural Quality Product (FEI: 3008179628) has 6 FDA import refusal record(s) in our database, spanning from 1/6/2012 to 5/9/2012.
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. Shavit Natural Quality Product's FEI number is 3008179628.
What types of violations has Shavit Natural Quality Product received?
Shavit Natural Quality Product has been cited for 9 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 Shavit Natural Quality Product come from?
All FDA import refusal data for Shavit Natural Quality Product 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.