Wavelength Enterprises Ltd.
⚠️ Moderate Risk
FEI: 3002806718 • Beer Sheva • ISRAEL
FEI Number
3002806718
Location
Beer Sheva
Country
ISRAELAddress
Eco Industrial Park, Neot Hovav, Southern District, Beer Sheva, , 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
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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 |
|---|---|---|---|
| 6/12/2012 | 60PCS03MIDAZOLAM HYDROCHLORIDE (ANESTHESIA ADJUNCT) | 72NEW VET DR | Philadelphia District Office (PHI-DO) |
| 1/30/2006 | 60LCR69TRAMADOL HCL (ANALGESIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/19/2006 | 61JCR09FENOFIBRATE (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/19/2006 | 60LCR69TRAMADOL HCL (ANALGESIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Wavelength Enterprises Ltd.'s FDA import refusal history?
Wavelength Enterprises Ltd. (FEI: 3002806718) has 4 FDA import refusal record(s) in our database, spanning from 1/19/2006 to 6/12/2012.
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. Wavelength Enterprises Ltd.'s FEI number is 3002806718.
What types of violations has Wavelength Enterprises Ltd. received?
Wavelength Enterprises 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 Wavelength Enterprises Ltd. come from?
All FDA import refusal data for Wavelength Enterprises 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.