Wenzhou Shengwei Electron Co., Ltd.

⚠️ Moderate Risk

FEI: 3008864602 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3008864602

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA

🏢

Address

69 Jinheng Road, Jinao Village, Linjiang Town, Wenzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

38.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

1/9/2018

Latest Refusal

5/6/2010

Earliest Refusal

Score Breakdown

Violation Severity

67.8×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

9.1×10%

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

477×

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.

2232×

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.

Refusal History

Date	Product	Violations	Division
1/9/2018	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of West Coast Imports (DWCI)
1/9/2018	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of West Coast Imports (DWCI)
12/19/2017	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of Southwest Imports (DSWI)
2/21/2013	95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS	47NON STD	Seattle District Office (SEA-DO)
11/17/2010	95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS	47NON STD	Los Angeles District Office (LOS-DO)
5/6/2010	95REJTOY, NOVELTY, PLAY LASER PRODUCT	223FALSE 47NON STD	Los Angeles District Office (LOS-DO)
5/6/2010	95REJTOY, NOVELTY, PLAY LASER PRODUCT	223FALSE 47NON STD	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Wenzhou Shengwei Electron Co., Ltd.'s FDA import refusal history?

Wenzhou Shengwei Electron Co., Ltd. (FEI: 3008864602) has 7 FDA import refusal record(s) in our database, spanning from 5/6/2010 to 1/9/2018.

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. Wenzhou Shengwei Electron Co., Ltd.'s FEI number is 3008864602.

What types of violations has Wenzhou Shengwei Electron Co., Ltd. received?

Wenzhou Shengwei Electron 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 Wenzhou Shengwei Electron Co., Ltd. come from?

All FDA import refusal data for Wenzhou Shengwei Electron 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.