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Roche Pharma

⚠️ Moderate Risk

FEI: 3005464934 • Reinach BL, Basel Landschaft • SWITZERLAND

FEI

FEI Number

3005464934

📍

Location

Reinach BL, Basel Landschaft

🇨🇭
🏢

Address

Schonmattstrasse 2, , Reinach BL, Basel Landschaft, Switzerland

Moderate Risk

FDA Import Risk Assessment

44.0
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
11/13/2009
Latest Refusal
2/12/2002
Earliest Refusal

Score Breakdown

Violation Severity
86.7×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
6.5×10%
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

755×

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).

3421×

PERSONALRX

The article appears to be a drug which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
11/13/2009
62VCF45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL)
75UNAPPROVED
New York District Office (NYK-DO)
3/12/2008
62ICA72CAPECITABINE (ANTI-NEOPLASTIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
3/12/2008
62ICA72CAPECITABINE (ANTI-NEOPLASTIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/23/2004
60RCA18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/12/2002
64FCF99ENZYME INHIBITOR N.E.C.
342PERSONALRX
75UNAPPROVED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Roche Pharma's FDA import refusal history?

Roche Pharma (FEI: 3005464934) has 5 FDA import refusal record(s) in our database, spanning from 2/12/2002 to 11/13/2009.

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 Pharma's FEI number is 3005464934.

What types of violations has Roche Pharma received?

Roche Pharma has been cited for 2 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 Pharma come from?

All FDA import refusal data for Roche Pharma 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.