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Xceed Health Solutions

⚠️ Moderate Risk

FEI: 3011968433 • Markham, Ontario • CANADA

FEI

FEI Number

3011968433

📍

Location

Markham, Ontario

🇨🇦

Country

CANADA
🏢

Address

179 the Meadows Ave, , Markham, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/10/2016
Latest Refusal
2/10/2016
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

4881×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

751×

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
2/10/2016
54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
488HEALTH C
75UNAPPROVED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Xceed Health Solutions's FDA import refusal history?

Xceed Health Solutions (FEI: 3011968433) has 1 FDA import refusal record(s) in our database, spanning from 2/10/2016 to 2/10/2016.

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. Xceed Health Solutions's FEI number is 3011968433.

What types of violations has Xceed Health Solutions received?

Xceed Health Solutions 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 Xceed Health Solutions come from?

All FDA import refusal data for Xceed Health Solutions 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.