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Alopecia Free

⚠️ Moderate Risk

FEI: 3012075533 • Belleville, Ontario • CANADA

FEI

FEI Number

3012075533

📍

Location

Belleville, Ontario

🇨🇦

Country

CANADA
🏢

Address

Suite #3083RD Floor, 99 Sidney St, Belleville, Ontario, 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
1
Unique Violations
3/15/2016
Latest Refusal
3/15/2016
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

162×

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
3/15/2016
65RAJ99REPLENISHER N.E.C.
16DIRECTIONS
Detroit District Office (DET-DO)
3/15/2016
65RAJ99REPLENISHER N.E.C.
16DIRECTIONS
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Alopecia Free's FDA import refusal history?

Alopecia Free (FEI: 3012075533) has 2 FDA import refusal record(s) in our database, spanning from 3/15/2016 to 3/15/2016.

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. Alopecia Free's FEI number is 3012075533.

What types of violations has Alopecia Free received?

Alopecia Free 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 Alopecia Free come from?

All FDA import refusal data for Alopecia Free 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.