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St Nikola 2013 Ltd

⚠️ Moderate Risk

FEI: 3011381644 • Sofia • BULGARIA

FEI

FEI Number

3011381644

📍

Location

Sofia

🇧🇬

Country

BULGARIA
🏢

Address

Stamboliiski Lvd 108 Al, , Sofia, , Bulgaria

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
4/10/2015
Latest Refusal
4/10/2015
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

38631×

PLANT PART

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.

751×

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).

Refusal History

DateProductViolationsDivision
4/10/2015
54YEK99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3863PLANT PART
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is St Nikola 2013 Ltd's FDA import refusal history?

St Nikola 2013 Ltd (FEI: 3011381644) has 1 FDA import refusal record(s) in our database, spanning from 4/10/2015 to 4/10/2015.

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. St Nikola 2013 Ltd's FEI number is 3011381644.

What types of violations has St Nikola 2013 Ltd received?

St Nikola 2013 Ltd 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 St Nikola 2013 Ltd come from?

All FDA import refusal data for St Nikola 2013 Ltd 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.