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Smithkline-Beecham Phar

⚠️ High Risk

FEI: 3003462991 • Oakville, ON • CANADA

FEI

FEI Number

3003462991

📍

Location

Oakville, ON

🇨🇦

Country

CANADA
🏢

Address

Oakville,Ontario, , Oakville, ON, Canada

High Risk

FDA Import Risk Assessment

51.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
1
Unique Violations
11/20/2001
Latest Refusal
11/20/2001
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

756×

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
11/20/2001
61NCY99ANTI-DEPRESSANT N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/20/2001
62GIY99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/20/2001
62GIY97NABUMETONE (ANTI-INFLAMMATORY)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/20/2001
61NCY99ANTI-DEPRESSANT N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/20/2001
61NCY99ANTI-DEPRESSANT N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/20/2001
61PCY99ANTI-DIABETIC N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Smithkline-Beecham Phar's FDA import refusal history?

Smithkline-Beecham Phar (FEI: 3003462991) has 6 FDA import refusal record(s) in our database, spanning from 11/20/2001 to 11/20/2001.

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. Smithkline-Beecham Phar's FEI number is 3003462991.

What types of violations has Smithkline-Beecham Phar received?

Smithkline-Beecham Phar 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 Smithkline-Beecham Phar come from?

All FDA import refusal data for Smithkline-Beecham Phar 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.