Dr M Burstein Ltd
⚠️ Moderate Risk
FEI: 3009001137 • Ashkelon • ISRAEL
FEI Number
3009001137
Location
Ashkelon
Country
ISRAELAddress
209 Hataasia Streetnorth Industrial, , Ashkelon, , 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).
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.
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).
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 |
|---|---|---|---|
| 3/16/2015 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 4/16/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 9/20/2011 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 9/20/2011 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 9/20/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Dr M Burstein Ltd's FDA import refusal history?
Dr M Burstein Ltd (FEI: 3009001137) has 5 FDA import refusal record(s) in our database, spanning from 9/20/2011 to 3/16/2015.
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. Dr M Burstein Ltd's FEI number is 3009001137.
What types of violations has Dr M Burstein Ltd received?
Dr M Burstein 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 Dr M Burstein Ltd come from?
All FDA import refusal data for Dr M Burstein 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.