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John Hawrylak

⚠️ Moderate Risk

FEI: 3005525469 • Sydney, NS • CANADA

FEI

FEI Number

3005525469

📍

Location

Sydney, NS

🇨🇦

Country

CANADA
🏢

Address

197 Vulcam Ave, , Sydney, NS, 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
2
Unique Violations
2/2/2006
Latest Refusal
2/2/2006
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

3312×

DR QUALITC

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.

161×

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
2/2/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
331DR QUALITC
New Orleans District Office (NOL-DO)
2/2/2006
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
331DR QUALITC
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is John Hawrylak's FDA import refusal history?

John Hawrylak (FEI: 3005525469) has 2 FDA import refusal record(s) in our database, spanning from 2/2/2006 to 2/2/2006.

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. John Hawrylak's FEI number is 3005525469.

What types of violations has John Hawrylak received?

John Hawrylak 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 John Hawrylak come from?

All FDA import refusal data for John Hawrylak 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.