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ZHANGQIANLIANG

⚠️ Moderate Risk

FEI: 3021810551 • Beijing • CHINA

FEI

FEI Number

3021810551

📍

Location

Beijing

🇨🇳

Country

CHINA
🏢

Address

Beijing Chaoyang, No. 745 Yangshugang; Dist,Jinzhanxiang, Beijing, , China

Moderate Risk

FDA Import Risk Assessment

42.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
8/26/2025
Latest Refusal
8/26/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
92.3×20%
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).

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).

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
8/26/2025
76QJKINTRAORAL CAMERA
118NOT LISTED
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ZHANGQIANLIANG's FDA import refusal history?

ZHANGQIANLIANG (FEI: 3021810551) has 1 FDA import refusal record(s) in our database, spanning from 8/26/2025 to 8/26/2025.

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. ZHANGQIANLIANG's FEI number is 3021810551.

What types of violations has ZHANGQIANLIANG received?

ZHANGQIANLIANG has been cited for 3 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 ZHANGQIANLIANG come from?

All FDA import refusal data for ZHANGQIANLIANG 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.