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Ningbo Troika Science & Technology Co.,Ltd.

⚠️ Moderate Risk

FEI: 3010673773 • Ningbo, Zhejiang • CHINA

FEI

FEI Number

3010673773

📍

Location

Ningbo, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

11 Gaoya Rd, Jiangshan Town, Yinzhou District, Ningbo, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

38.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
5
Unique Violations
8/21/2025
Latest Refusal
8/21/2025
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
92.2×20%
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).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

39041×

3904

39051×

3905

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
8/21/2025
84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
118NOT LISTED
223FALSE
39043904
39053905
508NO 510(K)
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Ningbo Troika Science & Technology Co.,Ltd.'s FDA import refusal history?

Ningbo Troika Science & Technology Co.,Ltd. (FEI: 3010673773) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2025 to 8/21/2025.

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. Ningbo Troika Science & Technology Co.,Ltd.'s FEI number is 3010673773.

What types of violations has Ningbo Troika Science & Technology Co.,Ltd. received?

Ningbo Troika Science & Technology Co.,Ltd. has been cited for 5 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 Ningbo Troika Science & Technology Co.,Ltd. come from?

All FDA import refusal data for Ningbo Troika Science & Technology 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.