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SICOR Societa' Italiana Corticosteroidi s.r.l.

⚠️ Moderate Risk

FEI: 3002807245 • Settimo Milanese, Milan • ITALY

FEI

FEI Number

3002807245

📍

Location

Settimo Milanese, Milan

🇮🇹

Country

ITALY
🏢

Address

Via Enrico Fermi 20/26, , Settimo Milanese, Milan, Italy

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/23/2010
Latest Refusal
7/23/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
7/23/2010
64LCS26FLUNISOLIDE (GLUCOCORTICOID)
27DRUG GMPS
New York District Office (NYK-DO)

Frequently Asked Questions

What is SICOR Societa' Italiana Corticosteroidi s.r.l.'s FDA import refusal history?

SICOR Societa' Italiana Corticosteroidi s.r.l. (FEI: 3002807245) has 1 FDA import refusal record(s) in our database, spanning from 7/23/2010 to 7/23/2010.

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. SICOR Societa' Italiana Corticosteroidi s.r.l.'s FEI number is 3002807245.

What types of violations has SICOR Societa' Italiana Corticosteroidi s.r.l. received?

SICOR Societa' Italiana Corticosteroidi s.r.l. 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 SICOR Societa' Italiana Corticosteroidi s.r.l. come from?

All FDA import refusal data for SICOR Societa' Italiana Corticosteroidi s.r.l. 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.