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Cover FX Skincare Inc.

⚠️ Moderate Risk

FEI: 3004612704 • North York, Ontario • CANADA

FEI

FEI Number

3004612704

📍

Location

North York, Ontario

🇨🇦

Country

CANADA
🏢

Address

1681 Flint Rd, , North York, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

26.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
9/15/2011
Latest Refusal
9/13/2011
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
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

1182×

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).

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
9/15/2011
62SBJ99ANTI-SEBORRHEIC N.E.C.
118NOT LISTED
Detroit District Office (DET-DO)
9/13/2011
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
336INCONSPICU
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Cover FX Skincare Inc.'s FDA import refusal history?

Cover FX Skincare Inc. (FEI: 3004612704) has 2 FDA import refusal record(s) in our database, spanning from 9/13/2011 to 9/15/2011.

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. Cover FX Skincare Inc.'s FEI number is 3004612704.

What types of violations has Cover FX Skincare Inc. received?

Cover FX Skincare Inc. 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 Cover FX Skincare Inc. come from?

All FDA import refusal data for Cover FX Skincare 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.