ImportRefusal LogoImportRefusal

Wioletta Gornisiewicz

⚠️ Moderate Risk

FEI: 3004409936 • Cracow, Malopolskie • POLAND

FEI

FEI Number

3004409936

📍

Location

Cracow, Malopolskie

🇵🇱

Country

POLAND
🏢

Address

Ul. nad Potokiem 8/52, , Cracow, Malopolskie, Poland

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
2/4/2004
Latest Refusal
2/4/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

752×

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).

4721×

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

DateProductViolationsDivision
2/4/2004
54AEB90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
472NO ENGLISH
New Orleans District Office (NOL-DO)
2/4/2004
60LCB99ANALGESIC, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/4/2004
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Wioletta Gornisiewicz's FDA import refusal history?

Wioletta Gornisiewicz (FEI: 3004409936) has 3 FDA import refusal record(s) in our database, spanning from 2/4/2004 to 2/4/2004.

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. Wioletta Gornisiewicz's FEI number is 3004409936.

What types of violations has Wioletta Gornisiewicz received?

Wioletta Gornisiewicz 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 Wioletta Gornisiewicz come from?

All FDA import refusal data for Wioletta Gornisiewicz 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.