ImportRefusal LogoImportRefusal

GOODMI INTELLIGENT CO. LTD

⚠️ Moderate Risk

FEI: 3023626449 • Shenzhen • CHINA

FEI

FEI Number

3023626449

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

2/F Building 125, No. 7, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

34.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/26/2023
Latest Refusal
6/26/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
48.5×20%
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).

Refusal History

DateProductViolationsDivision
6/26/2023
77QUFHEARING AID, AIR-CONDUCTION, OVER THE COUNTER
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GOODMI INTELLIGENT CO. LTD's FDA import refusal history?

GOODMI INTELLIGENT CO. LTD (FEI: 3023626449) has 1 FDA import refusal record(s) in our database, spanning from 6/26/2023 to 6/26/2023.

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. GOODMI INTELLIGENT CO. LTD's FEI number is 3023626449.

What types of violations has GOODMI INTELLIGENT CO. LTD received?

GOODMI INTELLIGENT CO. LTD 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 GOODMI INTELLIGENT CO. LTD come from?

All FDA import refusal data for GOODMI INTELLIGENT 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.