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Guangzhou Jimy Facial & Hair Beauty Products CO., LTD

⚠️ Moderate Risk

FEI: 3009548468 • Foshan, Guangdong • CHINA

FEI

FEI Number

3009548468

📍

Location

Foshan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Pingdong Dashengcun, Pingzhouzhen Nanhai District, Foshan, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
5/14/2012
Latest Refusal
5/14/2012
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

3411×

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

DateProductViolationsDivision
5/14/2012
89IMIDIATHERMY, ULTRASONIC, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
118NOT LISTED
237NO PMA
341REGISTERED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Guangzhou Jimy Facial & Hair Beauty Products CO., LTD's FDA import refusal history?

Guangzhou Jimy Facial & Hair Beauty Products CO., LTD (FEI: 3009548468) has 1 FDA import refusal record(s) in our database, spanning from 5/14/2012 to 5/14/2012.

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 Jimy Facial & Hair Beauty Products CO., LTD's FEI number is 3009548468.

What types of violations has Guangzhou Jimy Facial & Hair Beauty Products CO., LTD received?

Guangzhou Jimy Facial & Hair Beauty Products 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 Guangzhou Jimy Facial & Hair Beauty Products CO., LTD come from?

All FDA import refusal data for Guangzhou Jimy Facial & Hair Beauty Products 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.