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Universal Drug Ser

⚠️ High Risk

FEI: 3006181452 • Winnipeg, MANITOBA • CANADA

FEI

FEI Number

3006181452

📍

Location

Winnipeg, MANITOBA

🇨🇦

Country

CANADA
🏢

Address

5b 851 Largi Modir, , Winnipeg, MANITOBA, Canada

High Risk

FDA Import Risk Assessment

59.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

16
Total Refusals
1
Unique Violations
7/23/2012
Latest Refusal
10/6/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
45.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

7516×

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
7/23/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/11/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/11/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/11/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/11/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/11/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/11/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/5/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/5/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/5/2012
65QDA22METHOCARBAMOL (RELAXANT)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/5/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/5/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/5/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/5/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/5/2012
66JCA99THYROID HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/6/2011
66JDA05THYROID (THYROID HORMONE)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Universal Drug Ser's FDA import refusal history?

Universal Drug Ser (FEI: 3006181452) has 16 FDA import refusal record(s) in our database, spanning from 10/6/2011 to 7/23/2012.

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. Universal Drug Ser's FEI number is 3006181452.

What types of violations has Universal Drug Ser received?

Universal Drug Ser 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 Universal Drug Ser come from?

All FDA import refusal data for Universal Drug Ser 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.