Shavit Import & Export
⚠️ Moderate Risk
FEI: 3008841146 • Tel Aviv • ISRAEL
FEI Number
3008841146
Location
Tel Aviv
Country
ISRAELAddress
64 Pinchas Rosen St, , 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
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.
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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/19/2011 | 26BCT02GRAIN OIL SEED STOCK | 2300DIETARYLBL | New England District Office (NWE-DO) |
| 7/19/2011 | 62MBY08MENTHOL (ANTI-PRURITIC) | New England District Office (NWE-DO) | |
| 7/19/2011 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 53UD12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 7/19/2011 | 61HBY99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 7/19/2011 | 61HBJ99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 7/19/2011 | 61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 7/19/2011 | 61HBY99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 7/19/2011 | 61HBY99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 7/19/2011 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 7/19/2011 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 7/19/2011 | 61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL) | 75UNAPPROVED | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Shavit Import & Export's FDA import refusal history?
Shavit Import & Export (FEI: 3008841146) has 23 FDA import refusal record(s) in our database, spanning from 7/19/2011 to 7/19/2011.
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 Import & Export's FEI number is 3008841146.
What types of violations has Shavit Import & Export received?
Shavit Import & Export has been cited for 5 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 Import & Export come from?
All FDA import refusal data for Shavit Import & Export 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.