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Charlotte Products Ltd.

⚠️ Moderate Risk

FEI: 3005959243 • Peterborough, Ontario • CANADA

FEI

FEI Number

3005959243

📍

Location

Peterborough, Ontario

🇨🇦

Country

CANADA
🏢

Address

2060 Fisher Dr, , Peterborough, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

27.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/17/2022
Latest Refusal
8/17/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
17.9×20%
Frequency
10.0×10%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
8/17/2022
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Charlotte Products Ltd.'s FDA import refusal history?

Charlotte Products Ltd. (FEI: 3005959243) has 1 FDA import refusal record(s) in our database, spanning from 8/17/2022 to 8/17/2022.

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. Charlotte Products Ltd.'s FEI number is 3005959243.

What types of violations has Charlotte Products Ltd. received?

Charlotte Products Ltd. 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 Charlotte Products Ltd. come from?

All FDA import refusal data for Charlotte Products Ltd. 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.