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TEVA ITALI SRL

⚠️ Moderate Risk

FEI: 3012783607 • Milan, Milan • ITALY

FEI

FEI Number

3012783607

📍

Location

Milan, Milan

🇮🇹

Country

ITALY
🏢

Address

Piazzale Luigi Cadorna, , Milan, Milan, Italy

Moderate Risk

FDA Import Risk Assessment

50.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/8/2023
Latest Refusal
4/8/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
41.2×20%
Frequency
4.4×10%
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).

Refusal History

DateProductViolationsDivision
11/8/2023
61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
4/8/2019
56CQR11CEFAZOLIN SODIUM (CEPHALOSPORINS)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TEVA ITALI SRL's FDA import refusal history?

TEVA ITALI SRL (FEI: 3012783607) has 2 FDA import refusal record(s) in our database, spanning from 4/8/2019 to 11/8/2023.

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. TEVA ITALI SRL's FEI number is 3012783607.

What types of violations has TEVA ITALI SRL received?

TEVA ITALI SRL 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 TEVA ITALI SRL come from?

All FDA import refusal data for TEVA ITALI SRL 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.