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Matrix

⚠️ Moderate Risk

FEI: 3004828983 • New York, NY • UNITED STATES

FEI

FEI Number

3004828983

📍

Location

New York, NY

🇺🇸
🏢

Address

575 5th Ave, , New York, NY, United States

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/2/2009
Latest Refusal
7/2/2009
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

1182×

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).

3352×

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.

Refusal History

DateProductViolationsDivision
7/2/2009
61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL)
118NOT LISTED
335LACKS N/C
New York District Office (NYK-DO)
7/2/2009
61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL)
118NOT LISTED
335LACKS N/C
New York District Office (NYK-DO)

Frequently Asked Questions

What is Matrix's FDA import refusal history?

Matrix (FEI: 3004828983) has 2 FDA import refusal record(s) in our database, spanning from 7/2/2009 to 7/2/2009.

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. Matrix's FEI number is 3004828983.

What types of violations has Matrix received?

Matrix 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 Matrix come from?

All FDA import refusal data for Matrix 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.