Jinan G Weike Science & Technology Co.,Ltd

⚠️ High Risk

FEI: 3009132636 • Jinan • CHINA

FEI

FEI Number

3009132636

📍

Location

Jinan

🇨🇳

Country

CHINA

🏢

Address

C-504 in Hi Tech Square Hig, Tech Zone, Jinan, , China

High Risk

FDA Import Risk Assessment

50.8

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

9/29/2023

Latest Refusal

1/17/2012

Earliest Refusal

Score Breakdown

Violation Severity

59.7×40%

Refusal Volume

48.2×30%

Recency

54.3×20%

Frequency

16.2×10%

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

4718×

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.

2787×

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).

4765×

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).

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

Date	Product	Violations	Division
9/29/2023	95RHKLASER MARKER OR ENGRAVER	47NON STD	Division of Southeast Imports (DSEI)
3/1/2023	95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS	278NO TAG 47NON STD	Division of Southeast Imports (DSEI)
2/16/2023	95RFRPRODUCT INCORPORATING CERTIFIED CLASS 1 LASER DATA MEASUREMENT, TRANSMIT, CONTROL	278NO TAG 47NON STD	Division of Southeast Imports (DSEI)
7/6/2022	95RHKLASER MARKER OR ENGRAVER	47NON STD	Division of Southwest Imports (DSWI)
3/9/2022	95RHKLASER MARKER OR ENGRAVER	47NON STD	Division of West Coast Imports (DWCI)
3/9/2022	95RHKLASER MARKER OR ENGRAVER	47NON STD	Division of West Coast Imports (DWCI)
3/9/2022	95RHKLASER MARKER OR ENGRAVER	47NON STD	Division of West Coast Imports (DWCI)
3/9/2022	95RHKLASER MARKER OR ENGRAVER	47NON STD	Division of West Coast Imports (DWCI)
2/16/2022	95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS	47NON STD	Division of Northeast Imports (DNEI)
1/14/2022	95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS	47NON STD	Division of Southwest Imports (DSWI)
9/23/2021	95RHKLASER MARKER OR ENGRAVER	278NO TAG 47NON STD	Division of West Coast Imports (DWCI)
9/16/2021	95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS	47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
11/13/2020	95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS	47NON STD	Division of West Coast Imports (DWCI)
2/21/2020	95RHKLASER MARKER OR ENGRAVER	278NO TAG 47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
2/21/2020	95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS	278NO TAG 47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
2/21/2020	95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS	278NO TAG 47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
2/21/2020	95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS	278NO TAG 47NON STD	Division of West Coast Imports (DWCI)
4/26/2017	95RHKLASER MARKER OR ENGRAVER	126FAILS STD 47NON STD	Division of Southeast Imports (DSEI)
1/17/2012	95RZNGENERAL INDUSTRIAL USE MATERIAL PROCESSING LASER PRODUCTS	476NO REGISTR	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Jinan G Weike Science & Technology Co.,Ltd's FDA import refusal history?

Jinan G Weike Science & Technology Co.,Ltd (FEI: 3009132636) has 19 FDA import refusal record(s) in our database, spanning from 1/17/2012 to 9/29/2023.

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. Jinan G Weike Science & Technology Co.,Ltd's FEI number is 3009132636.

What types of violations has Jinan G Weike Science & Technology Co.,Ltd received?

Jinan G Weike Science & Technology Co.,Ltd has been cited for 4 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 Jinan G Weike Science & Technology Co.,Ltd come from?

All FDA import refusal data for Jinan G Weike 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.