KPKA d.d. Novo Mesto
✅ Low Risk
FEI: 3009980668 • Novo Mesto, Novo mesto • SLOVENIA
FEI Number
3009980668
Location
Novo Mesto, Novo mesto
Country
SLOVENIAAddress
Belokranjska Cesta 47, , Novo Mesto, Novo mesto, Slovenia
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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
Frequently Asked Questions
What is KPKA d.d. Novo Mesto's FDA import refusal history?
KPKA d.d. Novo Mesto (FEI: 3009980668) has 1 FDA import refusal record(s) in our database, spanning from 5/22/2017 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. KPKA d.d. Novo Mesto's FEI number is 3009980668.
What types of violations has KPKA d.d. Novo Mesto received?
KPKA d.d. Novo Mesto 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 KPKA d.d. Novo Mesto come from?
All FDA import refusal data for KPKA 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.