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Mds Pharma Service

⚠️ Moderate Risk

FEI: 3004141719 • Mississauga, Ontario • CANADA

FEI

FEI Number

3004141719

📍

Location

Mississauga, Ontario

🇨🇦

Country

CANADA
🏢

Address

1980 Matheson Blvd E, , Mississauga, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

40.1
LowModerateHighCritical

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

Statistics

9
Total Refusals
1
Unique Violations
6/15/2011
Latest Refusal
10/6/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
90.0×10%
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

1189×

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).

Refusal History

DateProductViolationsDivision
6/15/2011
75OIBBLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
118NOT LISTED
New Orleans District Office (NOL-DO)
12/3/2010
75OIBBLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
118NOT LISTED
New Orleans District Office (NOL-DO)
12/3/2010
75OIBBLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
118NOT LISTED
New Orleans District Office (NOL-DO)
12/3/2010
75OIBBLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
118NOT LISTED
New Orleans District Office (NOL-DO)
11/16/2010
75OIBBLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
118NOT LISTED
New Orleans District Office (NOL-DO)
11/16/2010
75OIBBLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
118NOT LISTED
New Orleans District Office (NOL-DO)
11/16/2010
75OIBBLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
118NOT LISTED
New Orleans District Office (NOL-DO)
11/16/2010
75OIBBLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
118NOT LISTED
New Orleans District Office (NOL-DO)
10/6/2010
75OIBBLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Mds Pharma Service's FDA import refusal history?

Mds Pharma Service (FEI: 3004141719) has 9 FDA import refusal record(s) in our database, spanning from 10/6/2010 to 6/15/2011.

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. Mds Pharma Service's FEI number is 3004141719.

What types of violations has Mds Pharma Service received?

Mds Pharma Service 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 Mds Pharma Service come from?

All FDA import refusal data for Mds Pharma Service 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.