Lek d.d.
⚠️ High Risk
FEI: 3002807460 • Ljubljana, Ljubljana • SLOVENIA
FEI Number
3002807460
Location
Ljubljana, Ljubljana
Country
SLOVENIAAddress
Verovskova Ulica 57, , Ljubljana, Ljubljana, Slovenia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
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.
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 |
|---|---|---|---|
| 3/9/2023 | 66YAA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/7/2023 | 66SCA27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 63ODA06SUMATRIPTAN (ANTIMIGRAINE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2019 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/16/2018 | 56BCH03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/24/2017 | 65BAA01ACETYLCYSTEINE (MUCOLYTIC) | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 65BAA01ACETYLCYSTEINE (MUCOLYTIC) | Division of Northeast Imports (DNEI) | |
| 2/24/2017 | 61JCB16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/24/2017 | 61JCB16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/5/2016 | 62VDY73DOLUTEGRAVIR SODIUM (ANTI-VIRAL) | Division of Northeast Imports (DNEI) | |
| 6/1/2012 | 56YCK99ANTIBIOTIC N.E.C. | New York District Office (NYK-DO) | |
| 6/9/2010 | 62TCY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/8/2009 | 56KIY85VANCOMYCIN HYDROCHLORIDE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/10/2008 | 61JCS08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | New York District Office (NYK-DO) | |
| 10/30/2007 | 65QCA37AMINOPHYLLINE (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/18/2007 | 56YCL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/11/2006 | 66SCY27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Lek d.d.'s FDA import refusal history?
Lek d.d. (FEI: 3002807460) has 17 FDA import refusal record(s) in our database, spanning from 8/11/2006 to 3/9/2023.
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 d.d.'s FEI number is 3002807460.
What types of violations has Lek d.d. received?
Lek d.d. has been cited for 5 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 d.d. come from?
All FDA import refusal data for Lek d.d. 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.