Dr. M Burnstein Laboratories
⚠️ Moderate Risk
FEI: 3011079488 • Ashkelon • ISRAEL
FEI Number
3011079488
Location
Ashkelon
Country
ISRAELAddress
Hataasia St, North Industrial Zone, 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
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.
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2014 | 53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 11/20/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 11/20/2014 | 55QY58GLYCERIN (PHARMACEUTIC NECESSITY - SOLVENT) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Dr. M Burnstein Laboratories's FDA import refusal history?
Dr. M Burnstein Laboratories (FEI: 3011079488) has 3 FDA import refusal record(s) in our database, spanning from 11/20/2014 to 11/20/2014.
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 Burnstein Laboratories's FEI number is 3011079488.
What types of violations has Dr. M Burnstein Laboratories received?
Dr. M Burnstein Laboratories 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 Dr. M Burnstein Laboratories come from?
All FDA import refusal data for Dr. M Burnstein Laboratories 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.