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Quick Pack

⚠️ Moderate Risk

FEI: 3003628169 • Bois-Des-Filion, QC • CANADA

FEI

FEI Number

3003628169

📍

Location

Bois-Des-Filion, QC

🇨🇦

Country

CANADA
🏢

Address

870 Industriel, , Bois-Des-Filion, QC, Canada

Moderate Risk

FDA Import Risk Assessment

35.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
4
Unique Violations
4/17/2003
Latest Refusal
4/17/2003
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

3353×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

3443×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

3362×

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.

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
4/17/2003
63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
336INCONSPICU
473LABELING
Detroit District Office (DET-DO)
4/17/2003
63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
336INCONSPICU
473LABELING
Detroit District Office (DET-DO)
4/17/2003
63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
335LACKS N/C
344WARNINGS
Detroit District Office (DET-DO)
4/17/2003
63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
335LACKS N/C
344WARNINGS
Detroit District Office (DET-DO)
4/17/2003
63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
335LACKS N/C
344WARNINGS
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Quick Pack's FDA import refusal history?

Quick Pack (FEI: 3003628169) has 5 FDA import refusal record(s) in our database, spanning from 4/17/2003 to 4/17/2003.

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. Quick Pack's FEI number is 3003628169.

What types of violations has Quick Pack received?

Quick Pack has been cited for 4 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 Quick Pack come from?

All FDA import refusal data for Quick Pack 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.