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Aroma Crystal Therapy

⚠️ High Risk

FEI: 3008819311 • Coquitlam, BC • CANADA

FEI

FEI Number

3008819311

📍

Location

Coquitlam, BC

🇨🇦

Country

CANADA
🏢

Address

2403 Canoe Ave, , Coquitlam, BC, Canada

High Risk

FDA Import Risk Assessment

60.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

17
Total Refusals
1
Unique Violations
4/17/2012
Latest Refusal
4/3/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
46.5×30%
Recency
0.0×20%
Frequency
100.0×10%
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

7517×

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
4/17/2012
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/17/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/17/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/17/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53GC05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LI99OTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/3/2012
53GC05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Aroma Crystal Therapy's FDA import refusal history?

Aroma Crystal Therapy (FEI: 3008819311) has 17 FDA import refusal record(s) in our database, spanning from 4/3/2012 to 4/17/2012.

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. Aroma Crystal Therapy's FEI number is 3008819311.

What types of violations has Aroma Crystal Therapy received?

Aroma Crystal Therapy 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 Aroma Crystal Therapy come from?

All FDA import refusal data for Aroma Crystal Therapy 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.