New Age Laboratories Ltd
⚠️ Moderate Risk
FEI: 3008056489 • Giv'at Brenner • ISRAEL
FEI Number
3008056489
Location
Giv'at Brenner
Country
ISRAELAddress
Rimon I.Z, , Giv'at Brenner, , 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
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.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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 |
|---|---|---|---|
| 8/19/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 8/19/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 8/19/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 8/19/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 8/19/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 8/19/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 8/19/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 4/13/2010 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is New Age Laboratories Ltd's FDA import refusal history?
New Age Laboratories Ltd (FEI: 3008056489) has 8 FDA import refusal record(s) in our database, spanning from 4/13/2010 to 8/19/2010.
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. New Age Laboratories Ltd's FEI number is 3008056489.
What types of violations has New Age Laboratories Ltd received?
New Age Laboratories Ltd has been cited for 3 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 New Age Laboratories Ltd come from?
All FDA import refusal data for New Age Laboratories 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.