CHANGSHU WOJUN MACHINERY EQUIPME

⚠️ Moderate Risk

FEI: 3017150537 • Changshu • CHINA

FEI

FEI Number

3017150537

📍

Location

Changshu

🇨🇳

Country

CHINA

🏢

Address

Fuya Road Bldg 18, 7 Bi, Changshu, , China

Moderate Risk

FDA Import Risk Assessment

46.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/24/2021

Latest Refusal

10/8/2020

Earliest Refusal

Score Breakdown

Violation Severity

61.1×40%

Refusal Volume

40.0×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

478×

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.

4768×

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).

2782×

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).

Refusal History

Date	Product	Violations	Division
2/24/2021	95RHKLASER MARKER OR ENGRAVER	47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
2/24/2021	95RHKLASER MARKER OR ENGRAVER	47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
2/24/2021	95RHKLASER MARKER OR ENGRAVER	47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
2/24/2021	95RHKLASER MARKER OR ENGRAVER	47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
2/24/2021	95RHKLASER MARKER OR ENGRAVER	47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
2/24/2021	95RHKLASER MARKER OR ENGRAVER	47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
2/24/2021	95RHKLASER MARKER OR ENGRAVER	47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
2/10/2021	95RHKLASER MARKER OR ENGRAVER	278NO TAG	Division of Northeast Imports (DNEI)
2/10/2021	95RHKLASER MARKER OR ENGRAVER	278NO TAG	Division of Northeast Imports (DNEI)
1/13/2021	95RHKLASER MARKER OR ENGRAVER	47NON STD	Division of Southwest Imports (DSWI)
10/8/2020	95RHKLASER MARKER OR ENGRAVER	476NO REGISTR	Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is CHANGSHU WOJUN MACHINERY EQUIPME's FDA import refusal history?

CHANGSHU WOJUN MACHINERY EQUIPME (FEI: 3017150537) has 11 FDA import refusal record(s) in our database, spanning from 10/8/2020 to 2/24/2021.

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. CHANGSHU WOJUN MACHINERY EQUIPME's FEI number is 3017150537.

What types of violations has CHANGSHU WOJUN MACHINERY EQUIPME received?

CHANGSHU WOJUN MACHINERY EQUIPME 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 CHANGSHU WOJUN MACHINERY EQUIPME come from?

All FDA import refusal data for CHANGSHU WOJUN MACHINERY EQUIPME 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.