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Hoffmann La Roche

⚠️ Moderate Risk

FEI: 3000326016 • Cambridge, ON • CANADA

FEI

FEI Number

3000326016

📍

Location

Cambridge, ON

🇨🇦

Country

CANADA
🏢

Address

Hwy 97 & 401, , Cambridge, ON, Canada

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
4/20/2004
Latest Refusal
7/17/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

3085×

MFR INSAN

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

Refusal History

DateProductViolationsDivision
4/20/2004
54ALX01VITAMIN A
308MFR INSAN
New York District Office (NYK-DO)
7/17/2003
54ALX01VITAMIN A
308MFR INSAN
New York District Office (NYK-DO)
7/17/2003
54ALX01VITAMIN A
308MFR INSAN
New York District Office (NYK-DO)
7/17/2003
54ALX01VITAMIN A
308MFR INSAN
New York District Office (NYK-DO)
7/17/2003
54ALX01VITAMIN A
308MFR INSAN
New York District Office (NYK-DO)

Frequently Asked Questions

What is Hoffmann La Roche's FDA import refusal history?

Hoffmann La Roche (FEI: 3000326016) has 5 FDA import refusal record(s) in our database, spanning from 7/17/2003 to 4/20/2004.

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. Hoffmann La Roche's FEI number is 3000326016.

What types of violations has Hoffmann La Roche received?

Hoffmann La Roche 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 Hoffmann La Roche come from?

All FDA import refusal data for Hoffmann La Roche 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.