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Priya Pooran

⚠️ Moderate Risk

FEI: 3011903624 • Edmonton, Alberta • CANADA

FEI

FEI Number

3011903624

📍

Location

Edmonton, Alberta

🇨🇦

Country

CANADA
🏢

Address

2433 Ashcraft Cres SW, , Edmonton, Alberta, Canada

Moderate Risk

FDA Import Risk Assessment

41.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
5/3/2016
Latest Refusal
5/3/2016
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

4716×

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.

756×

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
5/3/2016
53JC01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
75UNAPPROVED
Seattle District Office (SEA-DO)
5/3/2016
53JC01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
75UNAPPROVED
Seattle District Office (SEA-DO)
5/3/2016
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
75UNAPPROVED
Seattle District Office (SEA-DO)
5/3/2016
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
75UNAPPROVED
Seattle District Office (SEA-DO)
5/3/2016
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
75UNAPPROVED
Seattle District Office (SEA-DO)
5/3/2016
53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Priya Pooran's FDA import refusal history?

Priya Pooran (FEI: 3011903624) has 6 FDA import refusal record(s) in our database, spanning from 5/3/2016 to 5/3/2016.

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. Priya Pooran's FEI number is 3011903624.

What types of violations has Priya Pooran received?

Priya Pooran 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 Priya Pooran come from?

All FDA import refusal data for Priya Pooran 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.