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Roche Diagnostic Corp

⚠️ Moderate Risk

FEI: 3006303226 • Graz • AUSTRALIA

FEI

FEI Number

3006303226

📍

Location

Graz

🇦🇺

Country

AUSTRALIA
🏢

Address

Kratkystrasse 2, , Graz, , Australia

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/9/2014
Latest Refusal
1/9/2014
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

24801×

RXPERSONAL

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

Refusal History

DateProductViolationsDivision
1/9/2014
81GJSTEST, TIME, PROTHROMBIN
16DIRECTIONS
2480RXPERSONAL
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Roche Diagnostic Corp's FDA import refusal history?

Roche Diagnostic Corp (FEI: 3006303226) has 1 FDA import refusal record(s) in our database, spanning from 1/9/2014 to 1/9/2014.

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 Diagnostic Corp's FEI number is 3006303226.

What types of violations has Roche Diagnostic Corp received?

Roche Diagnostic Corp 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 Diagnostic Corp come from?

All FDA import refusal data for Roche Diagnostic Corp 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.