ImportRefusal LogoImportRefusal

Teva Pharmaceuticals Ind Ltd

⚠️ Moderate Risk

FEI: 3005986950 • Kiryat Nordau • UNITED KINGDOM

FEI

FEI Number

3005986950

📍

Location

Kiryat Nordau

🇬🇧
🏢

Address

P.O. Box 8077, , Kiryat Nordau, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
1/6/2009
Latest Refusal
1/6/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
1/6/2009
60LAA99ANALGESIC, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
1/6/2009
66MAA95TEMAZEPAM (TRANQUILIZER)
75UNAPPROVED
New Orleans District Office (NOL-DO)
1/6/2009
61NDA66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Teva Pharmaceuticals Ind Ltd's FDA import refusal history?

Teva Pharmaceuticals Ind Ltd (FEI: 3005986950) has 3 FDA import refusal record(s) in our database, spanning from 1/6/2009 to 1/6/2009.

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 Pharmaceuticals Ind Ltd's FEI number is 3005986950.

What types of violations has Teva Pharmaceuticals Ind Ltd received?

Teva Pharmaceuticals Ind Ltd 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 Pharmaceuticals Ind Ltd come from?

All FDA import refusal data for Teva Pharmaceuticals Ind Ltd 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.