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Mint Pharmaceuticals

⚠️ Moderate Risk

FEI: 3009190314 • Mississauga, Ontario • CANADA

FEI

FEI Number

3009190314

📍

Location

Mississauga, Ontario

🇨🇦

Country

CANADA
🏢

Address

1093 Meyerside Dr, , Mississauga, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/15/2017
Latest Refusal
9/21/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
2/15/2017
64UDC06FINASTERIDE (INHIBITOR (DECARBOXYLASE))
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/21/2016
63EDY25MEXILETINE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/21/2016
62VDY01AMANTADINE HCL (ANTI-VIRAL)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Mint Pharmaceuticals's FDA import refusal history?

Mint Pharmaceuticals (FEI: 3009190314) has 3 FDA import refusal record(s) in our database, spanning from 9/21/2016 to 2/15/2017.

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. Mint Pharmaceuticals's FEI number is 3009190314.

What types of violations has Mint Pharmaceuticals received?

Mint Pharmaceuticals 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 Mint Pharmaceuticals come from?

All FDA import refusal data for Mint Pharmaceuticals 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.