L.S. Raw Materials, Ltd.
⚠️ Moderate Risk
FEI: 3003016927 • Petakh Tikva • ISRAEL
FEI Number
3003016927
Location
Petakh Tikva
Country
ISRAELAddress
30/3, Ha-Rav Kook, , Petakh Tikva, , 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/2/2006 | 66SCS39CYCLANDELATE (VASODILATOR) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 9/30/2004 | 64LAS67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/28/2004 | 61GAS47SULFADIAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 11/20/2003 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/20/2002 | 60NAS13STANOZOLOL (ANDROGEN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is L.S. Raw Materials, Ltd.'s FDA import refusal history?
L.S. Raw Materials, Ltd. (FEI: 3003016927) has 5 FDA import refusal record(s) in our database, spanning from 2/20/2002 to 11/2/2006.
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. L.S. Raw Materials, Ltd.'s FEI number is 3003016927.
What types of violations has L.S. Raw Materials, Ltd. received?
L.S. Raw Materials, Ltd. has been cited for 2 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 L.S. Raw Materials, Ltd. come from?
All FDA import refusal data for L.S. Raw Materials, 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.