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TRULY INSTRUMENT CO., LTD.

✅ Low Risk

FEI: 3003980573 • Shanwei, Guangdong • CHINA

FEI

FEI Number

3003980573

📍

Location

Shanwei, Guangdong

🇨🇳

Country

CHINA
🏢

Address

North of the Dong Chong Road, Truly Industrial Area, Shanwei, Guangdong, China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/10/2019
Latest Refusal
5/10/2019
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

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.

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
5/10/2019
74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
223FALSE
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TRULY INSTRUMENT CO., LTD.'s FDA import refusal history?

TRULY INSTRUMENT CO., LTD. (FEI: 3003980573) has 1 FDA import refusal record(s) in our database, spanning from 5/10/2019 to 5/10/2019.

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. TRULY INSTRUMENT CO., LTD.'s FEI number is 3003980573.

What types of violations has TRULY INSTRUMENT CO., LTD. received?

TRULY INSTRUMENT 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 TRULY INSTRUMENT CO., LTD. come from?

All FDA import refusal data for TRULY INSTRUMENT 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.