ImportRefusal LogoImportRefusal

Sigma Pharm

✅ Low Risk

FEI: 1000498252 • Vienna, Wien • AUSTRIA

FEI

FEI Number

1000498252

📍

Location

Vienna, Wien

🇦🇹

Country

AUSTRIA
🏢

Address

Leystrase 129, , Vienna, Wien, Austria

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/13/2006
Latest Refusal
6/13/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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).

Refusal History

DateProductViolationsDivision
6/13/2006
80KMJLUBRICANT, PATIENT
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sigma Pharm's FDA import refusal history?

Sigma Pharm (FEI: 1000498252) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2006 to 6/13/2006.

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. Sigma Pharm's FEI number is 1000498252.

What types of violations has Sigma Pharm received?

Sigma Pharm has been cited for 1 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 Sigma Pharm come from?

All FDA import refusal data for Sigma Pharm 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.