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SHANDONG TONGZHENG LASER EQUIPMENT CO., LTD

⚠️ Moderate Risk

FEI: 3017206483 • Liaocheng City, SHANDONG • CHINA

FEI

FEI Number

3017206483

📍

Location

Liaocheng City, SHANDONG

🇨🇳

Country

CHINA
🏢

Address

A17-1 LUXI INTERNATIONAL ENTERPRISE PIONEER PARK,, HAIYUAN ROAD, DONGCHANGFU DISTRICT,, Liaocheng City, SHANDONG, China

Moderate Risk

FDA Import Risk Assessment

31.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
10/5/2021
Latest Refusal
10/5/2021
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2783×

NO TAG

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

473×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

4763×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
10/5/2021
95RHKLASER MARKER OR ENGRAVER
278NO TAG
47NON STD
476NO REGISTR
Division of West Coast Imports (DWCI)
10/5/2021
95RHKLASER MARKER OR ENGRAVER
278NO TAG
47NON STD
476NO REGISTR
Division of West Coast Imports (DWCI)
10/5/2021
95RHKLASER MARKER OR ENGRAVER
278NO TAG
47NON STD
476NO REGISTR
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is SHANDONG TONGZHENG LASER EQUIPMENT CO., LTD's FDA import refusal history?

SHANDONG TONGZHENG LASER EQUIPMENT CO., LTD (FEI: 3017206483) has 3 FDA import refusal record(s) in our database, spanning from 10/5/2021 to 10/5/2021.

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. SHANDONG TONGZHENG LASER EQUIPMENT CO., LTD's FEI number is 3017206483.

What types of violations has SHANDONG TONGZHENG LASER EQUIPMENT CO., LTD received?

SHANDONG TONGZHENG LASER EQUIPMENT CO., LTD 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 SHANDONG TONGZHENG LASER EQUIPMENT CO., LTD come from?

All FDA import refusal data for SHANDONG TONGZHENG LASER EQUIPMENT 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.