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Roche Products Pty Ltd

⚠️ Moderate Risk

FEI: 1000251473 • Johannesburg, Gauteng • SOUTH AFRICA

FEI

FEI Number

1000251473

📍

Location

Johannesburg, Gauteng

🇿🇦
🏢

Address

PO Box 4589, , Johannesburg, Gauteng, South Africa

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/15/2005
Latest Refusal
9/15/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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
9/15/2005
63NBJ04DEXPANTHENOL (CHOLINERGIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Roche Products Pty Ltd's FDA import refusal history?

Roche Products Pty Ltd (FEI: 1000251473) has 1 FDA import refusal record(s) in our database, spanning from 9/15/2005 to 9/15/2005.

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 Products Pty Ltd's FEI number is 1000251473.

What types of violations has Roche Products Pty Ltd received?

Roche Products Pty 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 Roche Products Pty Ltd come from?

All FDA import refusal data for Roche Products Pty 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.