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Timm Medical Technologies

⚠️ Moderate Risk

FEI: 3004634367 • Mississauga, ON • CANADA

FEI

FEI Number

3004634367

📍

Location

Mississauga, ON

🇨🇦

Country

CANADA
🏢

Address

6695 Millcreek Drive,Unit #5, , Mississauga, ON, Canada

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/22/2004
Latest Refusal
10/21/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

24802×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
11/22/2004
78LKYDEVICE, EXTERNAL PENILE RIGIDITY
2480RXPERSONAL
New York District Office (NYK-DO)
10/21/2004
80KMOBINDER, ELASTIC
16DIRECTIONS
2480RXPERSONAL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Timm Medical Technologies's FDA import refusal history?

Timm Medical Technologies (FEI: 3004634367) has 2 FDA import refusal record(s) in our database, spanning from 10/21/2004 to 11/22/2004.

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. Timm Medical Technologies's FEI number is 3004634367.

What types of violations has Timm Medical Technologies received?

Timm Medical Technologies has been cited for 2 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 Timm Medical Technologies come from?

All FDA import refusal data for Timm Medical Technologies 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.