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Saint Michaels Wellesley Central Hospital

⚠️ Moderate Risk

FEI: 3002708086 • Toronto, Ontario • CANADA

FEI

FEI Number

3002708086

📍

Location

Toronto, Ontario

🇨🇦

Country

CANADA
🏢

Address

30 Bond St Suite 4103m, , Toronto, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

42.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/25/2006
Latest Refusal
10/14/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
7.0×10%
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

752×

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
8/25/2006
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/14/2003
66VIP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Saint Michaels Wellesley Central Hospital's FDA import refusal history?

Saint Michaels Wellesley Central Hospital (FEI: 3002708086) has 2 FDA import refusal record(s) in our database, spanning from 10/14/2003 to 8/25/2006.

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. Saint Michaels Wellesley Central Hospital's FEI number is 3002708086.

What types of violations has Saint Michaels Wellesley Central Hospital received?

Saint Michaels Wellesley Central Hospital 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 Saint Michaels Wellesley Central Hospital come from?

All FDA import refusal data for Saint Michaels Wellesley Central Hospital 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.