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Inovatyvus Sprendimai UAB

✅ Low Risk

FEI: 3014184224 • Kovno, Kauno • LITHUANIA

FEI

FEI Number

3014184224

📍

Location

Kovno, Kauno

🇱🇹

Country

LITHUANIA
🏢

Address

Birzelio 23-Iosios G. 1, , Kovno, Kauno, Lithuania

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
8/12/2019
Latest Refusal
8/12/2019
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

161×

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.

38701×

708NOENGL

Required label or labeling has been determined to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
8/12/2019
62UBY11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD)
16DIRECTIONS
3870708NOENGL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Inovatyvus Sprendimai UAB's FDA import refusal history?

Inovatyvus Sprendimai UAB (FEI: 3014184224) has 1 FDA import refusal record(s) in our database, spanning from 8/12/2019 to 8/12/2019.

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. Inovatyvus Sprendimai UAB's FEI number is 3014184224.

What types of violations has Inovatyvus Sprendimai UAB received?

Inovatyvus Sprendimai UAB has been cited for 2 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 Inovatyvus Sprendimai UAB come from?

All FDA import refusal data for Inovatyvus Sprendimai UAB 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.