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Carroll Hospital Group Inc

✅ Low Risk

FEI: 3007176145 • London, ON • CANADA

FEI

FEI Number

3007176145

📍

Location

London, ON

🇨🇦

Country

CANADA
🏢

Address

153 Towerline Place, , London, ON, Canada

Low Risk

FDA Import Risk Assessment

19.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
1
Unique Violations
5/17/2011
Latest Refusal
4/4/2011
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
5/17/2011
80FNLBED, AC-POWERED ADJUSTABLE HOSPITAL
341REGISTERED
Detroit District Office (DET-DO)
4/4/2011
80FNLBED, AC-POWERED ADJUSTABLE HOSPITAL
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Carroll Hospital Group Inc's FDA import refusal history?

Carroll Hospital Group Inc (FEI: 3007176145) has 2 FDA import refusal record(s) in our database, spanning from 4/4/2011 to 5/17/2011.

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. Carroll Hospital Group Inc's FEI number is 3007176145.

What types of violations has Carroll Hospital Group Inc received?

Carroll Hospital Group Inc 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 Carroll Hospital Group Inc come from?

All FDA import refusal data for Carroll Hospital Group Inc 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.