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Roche Pharmaceuticals(Israel) Lt

⚠️ Moderate Risk

FEI: 3005805783 • Petach Tikva • ISRAEL

FEI

FEI Number

3005805783

📍

Location

Petach Tikva

🇮🇱

Country

ISRAEL
🏢

Address

P.O Box 7543, , Petach Tikva, , Israel

Moderate Risk

FDA Import Risk Assessment

43.6
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/4/2009
Latest Refusal
7/24/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
9.1×10%
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
11/4/2009
65VCY15DIAZEPAM (SEDATIVE)
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/17/2007
62ICB72CAPECITABINE (ANTI-NEOPLASTIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
7/24/2006
60RCB18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Roche Pharmaceuticals(Israel) Lt's FDA import refusal history?

Roche Pharmaceuticals(Israel) Lt (FEI: 3005805783) has 3 FDA import refusal record(s) in our database, spanning from 7/24/2006 to 11/4/2009.

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. Roche Pharmaceuticals(Israel) Lt's FEI number is 3005805783.

What types of violations has Roche Pharmaceuticals(Israel) Lt received?

Roche Pharmaceuticals(Israel) Lt 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 Roche Pharmaceuticals(Israel) Lt come from?

All FDA import refusal data for Roche Pharmaceuticals(Israel) Lt 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.