Krka, d.d. Novo mesto
⚠️ High Risk
FEI: 3000478060 • Novo mesto, Jugovzhodna Slovenija • SLOVENIA
FEI Number
3000478060
Location
Novo mesto, Jugovzhodna Slovenija
Country
SLOVENIAAddress
Smarjeska cesta 6, , Novo mesto, Jugovzhodna Slovenija, 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 |
|---|---|---|---|
| 10/21/2025 | 61ECY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/7/2025 | 61JDE08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Division of West Coast Imports (DWCI) | |
| 7/16/2021 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2017 | 61JAY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2016 | 62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2016 | 62OCY12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2014 | 61NDY65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | Division of Northeast Imports (DNEI) | |
| 7/17/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/17/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/17/2013 | 54YCB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/2/2010 | 62MBH08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 12/2/2010 | 62MDH08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 7/9/2007 | 62LAP40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Krka, d.d. Novo mesto's FDA import refusal history?
Krka, d.d. Novo mesto (FEI: 3000478060) has 14 FDA import refusal record(s) in our database, spanning from 7/9/2007 to 10/21/2025.
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. Krka, d.d. Novo mesto's FEI number is 3000478060.
What types of violations has Krka, d.d. Novo mesto received?
Krka, d.d. Novo mesto 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 Krka, d.d. Novo mesto come from?
All FDA import refusal data for Krka, d.d. Novo mesto 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.