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Jamieson Laboratories Ltd

⚠️ Moderate Risk

FEI: 3004296697 • Windsor, Ontario • CANADA

FEI

FEI Number

3004296697

📍

Location

Windsor, Ontario

🇨🇦

Country

CANADA
🏢

Address

9650 Twin Oaks Dr, , Windsor, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
4/30/2003
Latest Refusal
4/30/2003
Earliest Refusal

Score Breakdown

Violation Severity
46.0×40%
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).

3362×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
4/30/2003
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
336INCONSPICU
483DRUG NAME
Detroit District Office (DET-DO)
4/30/2003
64ARL99DISINFECTANT N.E.C.
118NOT LISTED
336INCONSPICU
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Jamieson Laboratories Ltd's FDA import refusal history?

Jamieson Laboratories Ltd (FEI: 3004296697) has 2 FDA import refusal record(s) in our database, spanning from 4/30/2003 to 4/30/2003.

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. Jamieson Laboratories Ltd's FEI number is 3004296697.

What types of violations has Jamieson Laboratories Ltd received?

Jamieson Laboratories Ltd 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 Jamieson Laboratories Ltd come from?

All FDA import refusal data for Jamieson Laboratories 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.