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Tooth Fairy Corp

⚠️ Moderate Risk

FEI: 3003849535 • Windsor, ON • CANADA

FEI

FEI Number

3003849535

📍

Location

Windsor, ON

🇨🇦

Country

CANADA
🏢

Address

629 Hanley Ave On, , Windsor, ON, Canada

Moderate Risk

FDA Import Risk Assessment

32.0
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
1/16/2003
Latest Refusal
1/16/2003
Earliest Refusal

Score Breakdown

Violation Severity
46.0×40%
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

1183×

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).

4712×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
1/16/2003
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
471CSTIC LBLG
New York District Office (NYK-DO)
1/16/2003
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
471CSTIC LBLG
New York District Office (NYK-DO)
1/16/2003
76DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
118NOT LISTED
New York District Office (NYK-DO)
1/16/2003
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
New York District Office (NYK-DO)
1/16/2003
76EFTCLEANSER, DENTURE, OTC
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Tooth Fairy Corp's FDA import refusal history?

Tooth Fairy Corp (FEI: 3003849535) has 5 FDA import refusal record(s) in our database, spanning from 1/16/2003 to 1/16/2003.

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. Tooth Fairy Corp's FEI number is 3003849535.

What types of violations has Tooth Fairy Corp received?

Tooth Fairy Corp 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 Tooth Fairy Corp come from?

All FDA import refusal data for Tooth Fairy Corp 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.