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Dermabest Inc

⚠️ Moderate Risk

FEI: 3003751306 • York, ON • CANADA

FEI

FEI Number

3003751306

📍

Location

York, ON

🇨🇦

Country

CANADA
🏢

Address

5greentreect. Apt., , York, ON, Canada

Moderate Risk

FDA Import Risk Assessment

41.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
6/8/2005
Latest Refusal
6/8/2005
Earliest Refusal

Score Breakdown

Violation Severity
93.3×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1171×

DANGEROUS

The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.

3441×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

751×

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
6/8/2005
65GBJ99PIGMENTATION AGENT N.E.C.
117DANGEROUS
344WARNINGS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Dermabest Inc's FDA import refusal history?

Dermabest Inc (FEI: 3003751306) has 1 FDA import refusal record(s) in our database, spanning from 6/8/2005 to 6/8/2005.

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. Dermabest Inc's FEI number is 3003751306.

What types of violations has Dermabest Inc received?

Dermabest Inc has been cited for 3 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 Dermabest Inc come from?

All FDA import refusal data for Dermabest 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.