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GOODWIND TECHNOLOGY DEVELOPMENT CO, LTD

⚠️ Moderate Risk

FEI: 3009114618 • Hong Kong, Hong Kong • HONG KONG

FEI

FEI Number

3009114618

📍

Location

Hong Kong, Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

Rm 1101, 11/F, San Toi Building No. 139; Connaught Rd, Hong Kong, Hong Kong, Hong Kong

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/20/2012
Latest Refusal
7/20/2012
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
7/20/2012
79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION
118NOT LISTED
508NO 510(K)
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is GOODWIND TECHNOLOGY DEVELOPMENT CO, LTD's FDA import refusal history?

GOODWIND TECHNOLOGY DEVELOPMENT CO, LTD (FEI: 3009114618) has 1 FDA import refusal record(s) in our database, spanning from 7/20/2012 to 7/20/2012.

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. GOODWIND TECHNOLOGY DEVELOPMENT CO, LTD's FEI number is 3009114618.

What types of violations has GOODWIND TECHNOLOGY DEVELOPMENT CO, LTD received?

GOODWIND TECHNOLOGY DEVELOPMENT CO, LTD 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 GOODWIND TECHNOLOGY DEVELOPMENT CO, LTD come from?

All FDA import refusal data for GOODWIND TECHNOLOGY DEVELOPMENT CO, 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.