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SIGMATAU IND FARM RIUNITE SPA

⚠️ Moderate Risk

FEI: 3013333974 • Pomezia, Rome • ITALY

FEI

FEI Number

3013333974

📍

Location

Pomezia, Rome

🇮🇹

Country

ITALY
🏢

Address

Via Pontina KM 30,400, , Pomezia, Rome, Italy

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/4/2017
Latest Refusal
4/4/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
4/4/2017
61JCC14SIMVASTATIN (ANTI-CHOLESTEREMIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is SIGMATAU IND FARM RIUNITE SPA's FDA import refusal history?

SIGMATAU IND FARM RIUNITE SPA (FEI: 3013333974) has 1 FDA import refusal record(s) in our database, spanning from 4/4/2017 to 4/4/2017.

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. SIGMATAU IND FARM RIUNITE SPA's FEI number is 3013333974.

What types of violations has SIGMATAU IND FARM RIUNITE SPA received?

SIGMATAU IND FARM RIUNITE SPA 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 SIGMATAU IND FARM RIUNITE SPA come from?

All FDA import refusal data for SIGMATAU IND FARM RIUNITE SPA 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.