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Siodemka

⚠️ High Risk

FEI: 3004202965 • Elblag, Warminsko-Mazurskie • POLAND

FEI

FEI Number

3004202965

📍

Location

Elblag, Warminsko-Mazurskie

🇵🇱

Country

POLAND
🏢

Address

Ul. Henryka Sienkiewicza 7/8, , Elblag, Warminsko-Mazurskie, Poland

High Risk

FDA Import Risk Assessment

53.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

8
Total Refusals
2
Unique Violations
2/17/2004
Latest Refusal
2/17/2004
Earliest Refusal

Score Breakdown

Violation Severity
86.3×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

757×

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).

1791×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

Refusal History

DateProductViolationsDivision
2/17/2004
61QCY99ANTI-DIURETIC N.E.C.
179AGR RX
New Orleans District Office (NOL-DO)
2/17/2004
60LCP99ANALGESIC, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/17/2004
64TCP99IMMUNOSUPPRESS N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/17/2004
63FCP99CARDIOTONIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/17/2004
63FCP99CARDIOTONIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/17/2004
63FCP99CARDIOTONIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/17/2004
63FCP99CARDIOTONIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/17/2004
63FCP99CARDIOTONIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Siodemka's FDA import refusal history?

Siodemka (FEI: 3004202965) has 8 FDA import refusal record(s) in our database, spanning from 2/17/2004 to 2/17/2004.

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. Siodemka's FEI number is 3004202965.

What types of violations has Siodemka received?

Siodemka 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 Siodemka come from?

All FDA import refusal data for Siodemka 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.