ImportRefusal LogoImportRefusal

Hemosol

⚠️ Moderate Risk

FEI: 3003843710 • Mississauga, ON • CANADA

FEI

FEI Number

3003843710

📍

Location

Mississauga, ON

🇨🇦

Country

CANADA
🏢

Address

2585 Meadowpine Blvd, , Mississauga, ON, Canada

Moderate Risk

FDA Import Risk Assessment

31.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/21/2004
Latest Refusal
4/21/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
17.1×10%
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

2741×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

Refusal History

DateProductViolationsDivision
6/21/2004
33EYE99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
274COLOR LBLG
New Orleans District Office (NOL-DO)
4/21/2003
82MSTANTIBODIES, GLIADIN
237NO PMA
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Hemosol's FDA import refusal history?

Hemosol (FEI: 3003843710) has 2 FDA import refusal record(s) in our database, spanning from 4/21/2003 to 6/21/2004.

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. Hemosol's FEI number is 3003843710.

What types of violations has Hemosol received?

Hemosol 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 Hemosol come from?

All FDA import refusal data for Hemosol 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.