Lek Pharma.
⚠️ Moderate Risk
FEI: 3008332849 • Ljubljana • SLOVAKIA
FEI Number
3008332849
Location
Ljubljana
Country
SLOVAKIAAddress
Veroskova 57, , Ljubljana, , Slovakia
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/22/2017 | 65VBA99SEDATIVE N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/22/2017 | 66YBA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/22/2017 | 61XAA21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 6/22/2010 | 56DIS21GENTAMICIN SULFATE (AMINOGLYCOSIDES) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Lek Pharma.'s FDA import refusal history?
Lek Pharma. (FEI: 3008332849) has 4 FDA import refusal record(s) in our database, spanning from 6/22/2010 to 5/22/2017.
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. Lek Pharma.'s FEI number is 3008332849.
What types of violations has Lek Pharma. received?
Lek Pharma. has been cited for 4 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 Lek Pharma. come from?
All FDA import refusal data for Lek Pharma. 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.