ELKO Org. Ltd.
⚠️ Moderate Risk
FEI: 3006528422 • Unknown • SWITZERLAND
FEI Number
3006528422
Location
Unknown
Country
SWITZERLANDAddress
CH 6534 San Vittore GR, , Unknown, , Switzerland
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
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/8/2017 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 9/20/2012 | 64LBO06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 4/13/2010 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 483DRUG NAME | New York District Office (NYK-DO) |
| 4/13/2010 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 483DRUG NAME | New York District Office (NYK-DO) |
| 4/13/2010 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 483DRUG NAME | New York District Office (NYK-DO) |
| 4/13/2010 | 64LDO06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 483DRUG NAME | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ELKO Org. Ltd.'s FDA import refusal history?
ELKO Org. Ltd. (FEI: 3006528422) has 6 FDA import refusal record(s) in our database, spanning from 4/13/2010 to 9/8/2017.
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. ELKO Org. Ltd.'s FEI number is 3006528422.
What types of violations has ELKO Org. Ltd. received?
ELKO Org. 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 ELKO Org. Ltd. come from?
All FDA import refusal data for ELKO Org. 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.