Guangzhou Spon Body Beauty Equipmen

⚠️ Moderate Risk

FEI: 3009255338 • Guangzhou Cityguangzhou City • CHINA

FEI

FEI Number

3009255338

📍

Location

Guangzhou Cityguangzhou City

🇨🇳

Country

CHINA

🏢

Address

Xiangsheng 12th Street Huangbianxinshi, , Guangzhou Cityguangzhou City, , China

Moderate Risk

FDA Import Risk Assessment

30.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/19/2011

Latest Refusal

12/19/2011

Earliest Refusal

Score Breakdown

Violation Severity

42.9×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

50.0×10%

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

1185×

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).

3334×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

5083×

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.

3412×

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).

Refusal History

Date	Product	Violations	Division
12/19/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)
12/19/2011	79NSYSTIMULATOR, LIGHT, AESTHETIC	118NOT LISTED 333LACKS FIRM 508NO 510(K)	Cincinnati District Office (CIN-DO)
12/19/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 333LACKS FIRM 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
12/19/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 333LACKS FIRM 341REGISTERED	Cincinnati District Office (CIN-DO)
12/19/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 333LACKS FIRM	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Guangzhou Spon Body Beauty Equipmen's FDA import refusal history?

Guangzhou Spon Body Beauty Equipmen (FEI: 3009255338) has 5 FDA import refusal record(s) in our database, spanning from 12/19/2011 to 12/19/2011.

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. Guangzhou Spon Body Beauty Equipmen's FEI number is 3009255338.

What types of violations has Guangzhou Spon Body Beauty Equipmen received?

Guangzhou Spon Body Beauty Equipmen 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 Guangzhou Spon Body Beauty Equipmen come from?

All FDA import refusal data for Guangzhou Spon Body Beauty Equipmen 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.