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Quigley Manufacturing, Inc. dba Simon Candy Company

⚠️ Moderate Risk

FEI: 2510020 • Elizabethtown, PA • UNITED STATES

FEI

FEI Number

2510020

📍

Location

Elizabethtown, PA

🇺🇸
🏢

Address

31 N Spruce St, , Elizabethtown, PA, United States

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
12/16/2009
Latest Refusal
12/16/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
12/16/2009
62MAA08MENTHOL (ANTI-PRURITIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/16/2009
62MAA08MENTHOL (ANTI-PRURITIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/16/2009
62MAA08MENTHOL (ANTI-PRURITIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Quigley Manufacturing, Inc. dba Simon Candy Company's FDA import refusal history?

Quigley Manufacturing, Inc. dba Simon Candy Company (FEI: 2510020) has 3 FDA import refusal record(s) in our database, spanning from 12/16/2009 to 12/16/2009.

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. Quigley Manufacturing, Inc. dba Simon Candy Company's FEI number is 2510020.

What types of violations has Quigley Manufacturing, Inc. dba Simon Candy Company received?

Quigley Manufacturing, Inc. dba Simon Candy Company 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 Quigley Manufacturing, Inc. dba Simon Candy Company come from?

All FDA import refusal data for Quigley Manufacturing, Inc. dba Simon Candy Company 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.