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Hespeler Orthodontics Limited

⚠️ Moderate Risk

FEI: 3009955591 • Cambridge, Ontario • CANADA

FEI

FEI Number

3009955591

📍

Location

Cambridge, Ontario

🇨🇦

Country

CANADA
🏢

Address

298 Shepherd Ave, , Cambridge, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
11/5/2013
Latest Refusal
11/5/2013
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
11/5/2013
76EJFBRACKET, METAL, ORTHODONTIC
118NOT LISTED
New Orleans District Office (NOL-DO)
11/5/2013
76EJFBRACKET, METAL, ORTHODONTIC
118NOT LISTED
New Orleans District Office (NOL-DO)
11/5/2013
76DZCWIRE, ORTHODONTIC
118NOT LISTED
New Orleans District Office (NOL-DO)
11/5/2013
76DZDTUBE, ORTHODONTIC
118NOT LISTED
New Orleans District Office (NOL-DO)
11/5/2013
76EJFBRACKET, METAL, ORTHODONTIC
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Hespeler Orthodontics Limited's FDA import refusal history?

Hespeler Orthodontics Limited (FEI: 3009955591) has 5 FDA import refusal record(s) in our database, spanning from 11/5/2013 to 11/5/2013.

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. Hespeler Orthodontics Limited's FEI number is 3009955591.

What types of violations has Hespeler Orthodontics Limited received?

Hespeler Orthodontics Limited 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 Hespeler Orthodontics Limited come from?

All FDA import refusal data for Hespeler Orthodontics Limited 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.