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Suntech Medical, Inc.

✅ Low Risk

FEI: 1036863 • Morrisville, NC • UNITED STATES

FEI

FEI Number

1036863

📍

Location

Morrisville, NC

🇺🇸
🏢

Address

5827 S Miami Blvd Ste 100, , Morrisville, NC, United States

Low Risk

FDA Import Risk Assessment

21.9
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
11/23/2021
Latest Refusal
3/4/2013
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
2.0×20%
Frequency
2.3×10%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
11/23/2021
74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
3280FRNMFGREG
Division of Northern Border Imports (DNBI)
3/4/2013
74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Suntech Medical, Inc.'s FDA import refusal history?

Suntech Medical, Inc. (FEI: 1036863) has 2 FDA import refusal record(s) in our database, spanning from 3/4/2013 to 11/23/2021.

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. Suntech Medical, Inc.'s FEI number is 1036863.

What types of violations has Suntech Medical, Inc. received?

Suntech Medical, Inc. 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 Suntech Medical, Inc. come from?

All FDA import refusal data for Suntech Medical, Inc. 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.