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IDT Electronics (Shenzhen) Co., Ltd.

⚠️ Moderate Risk

FEI: 3002482349 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3002482349

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

East of 1a of Block 33, Chentian Industr, Baoan, Shenzhen, Guangdong, China

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
11/25/2011
Latest Refusal
11/25/2011
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
11/25/2011
74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is IDT Electronics (Shenzhen) Co., Ltd.'s FDA import refusal history?

IDT Electronics (Shenzhen) Co., Ltd. (FEI: 3002482349) has 1 FDA import refusal record(s) in our database, spanning from 11/25/2011 to 11/25/2011.

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. IDT Electronics (Shenzhen) Co., Ltd.'s FEI number is 3002482349.

What types of violations has IDT Electronics (Shenzhen) Co., Ltd. received?

IDT Electronics (Shenzhen) 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 IDT Electronics (Shenzhen) Co., Ltd. come from?

All FDA import refusal data for IDT Electronics (Shenzhen) 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.