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FUSION ORTHOPEDICS USA

⚠️ Moderate Risk

FEI: 3013365802 • Mesa, AZ • UNITED STATES

FEI

FEI Number

3013365802

📍

Location

Mesa, AZ

🇺🇸
🏢

Address

4135 S Power Rd Ste 118, , Mesa, AZ, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/18/2017
Latest Refusal
10/18/2017
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
10/18/2017
87HWCSCREW, FIXATION, BONE
2780DEVICEGMPS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FUSION ORTHOPEDICS USA's FDA import refusal history?

FUSION ORTHOPEDICS USA (FEI: 3013365802) has 1 FDA import refusal record(s) in our database, spanning from 10/18/2017 to 10/18/2017.

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. FUSION ORTHOPEDICS USA's FEI number is 3013365802.

What types of violations has FUSION ORTHOPEDICS USA received?

FUSION ORTHOPEDICS USA 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 FUSION ORTHOPEDICS USA come from?

All FDA import refusal data for FUSION ORTHOPEDICS USA 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.