ImportRefusal LogoImportRefusal

Diagnostic Biochem Canada Inc.

⚠️ Moderate Risk

FEI: 3002806808 • London, ON • CANADA

FEI

FEI Number

3002806808

📍

Location

London, ON

🇨🇦

Country

CANADA
🏢

Address

11-1020 Hargrieve Road, , London, ON, Canada

Moderate Risk

FDA Import Risk Assessment

28.9
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
9/30/2002
Latest Refusal
10/1/2001
Earliest Refusal

Score Breakdown

Violation Severity
54.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
9/30/2002
88LDTREAGENT, GENERAL PURPOSE
118NOT LISTED
341REGISTERED
508NO 510(K)
New York District Office (NYK-DO)
10/1/2001
88LDTREAGENT, GENERAL PURPOSE
118NOT LISTED
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is Diagnostic Biochem Canada Inc.'s FDA import refusal history?

Diagnostic Biochem Canada Inc. (FEI: 3002806808) has 2 FDA import refusal record(s) in our database, spanning from 10/1/2001 to 9/30/2002.

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. Diagnostic Biochem Canada Inc.'s FEI number is 3002806808.

What types of violations has Diagnostic Biochem Canada Inc. received?

Diagnostic Biochem Canada Inc. has been cited for 3 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 Diagnostic Biochem Canada Inc. come from?

All FDA import refusal data for Diagnostic Biochem Canada Inc. 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.