ImportRefusal LogoImportRefusal

University Of Pei

⚠️ Moderate Risk

FEI: 3000301944 • Charlottetown, PE • CANADA

FEI

FEI Number

3000301944

📍

Location

Charlottetown, PE

🇨🇦

Country

CANADA
🏢

Address

550 University-Path-Micr, , Charlottetown, PE, Canada

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/20/2003
Latest Refusal
9/22/2003
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

1791×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
11/20/2003
64LCA64TRIAMCINOLONE HEXACETONIDE (GLUCOCORTICOID)
72NEW VET DR
New Orleans District Office (NOL-DO)
9/22/2003
63AQY08SEVELAMER HCL (BONE CALCIUM REGULATOR)
179AGR RX
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is University Of Pei's FDA import refusal history?

University Of Pei (FEI: 3000301944) has 2 FDA import refusal record(s) in our database, spanning from 9/22/2003 to 11/20/2003.

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. University Of Pei's FEI number is 3000301944.

What types of violations has University Of Pei received?

University Of Pei 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 University Of Pei come from?

All FDA import refusal data for University Of Pei 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.