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Guangzhou Jinyimei

⚠️ Moderate Risk

FEI: 3005990926 • Guangzhou • CHINA

FEI

FEI Number

3005990926

📍

Location

Guangzhou

🇨🇳

Country

CHINA
🏢

Address

64 Heugqigang Rd, , Guangzhou, , China

Moderate Risk

FDA Import Risk Assessment

42.6
LowModerateHighCritical

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

Statistics

50
Total Refusals
3
Unique Violations
5/26/2008
Latest Refusal
3/3/2008
Earliest Refusal

Score Breakdown

Violation Severity
34.1×40%
Refusal Volume
63.3×30%
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

© ImportRefusal.com Original Analysis

Violation Summary

34141×

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).

1189×

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).

4761×

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).

Refusal History

DateProductViolationsDivision
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
95RHGLIGHT, SPECTRUM, BROAD (NON-MEDICAL), GENERAL OPTICAL PRODUCTS, NON-MEDICAL
476NO REGISTR
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
79OBSLIGHT EMITTING SYSTEM, LOW LEVEL, BIOSTIMULATION
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
79OBSLIGHT EMITTING SYSTEM, LOW LEVEL, BIOSTIMULATION
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
95RHGLIGHT, SPECTRUM, BROAD (NON-MEDICAL), GENERAL OPTICAL PRODUCTS, NON-MEDICAL
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
95RHGLIGHT, SPECTRUM, BROAD (NON-MEDICAL), GENERAL OPTICAL PRODUCTS, NON-MEDICAL
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
95RHGLIGHT, SPECTRUM, BROAD (NON-MEDICAL), GENERAL OPTICAL PRODUCTS, NON-MEDICAL
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
95RHGLIGHT, SPECTRUM, BROAD (NON-MEDICAL), GENERAL OPTICAL PRODUCTS, NON-MEDICAL
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
79OBSLIGHT EMITTING SYSTEM, LOW LEVEL, BIOSTIMULATION
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
97RALMASSAGER, ULTRASONIC NON-MEDICAL DEVICES
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
97RALMASSAGER, ULTRASONIC NON-MEDICAL DEVICES
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Los Angeles District Office (LOS-DO)
5/26/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)
3/3/2008
89LBGDEVICE, FLUIDIZED THERAPY, DRY HEAT
118NOT LISTED
Southwest Import District Office (SWI-DO)
3/3/2008
89IRTPAD, HEATING, POWERED
118NOT LISTED
Southwest Import District Office (SWI-DO)
3/3/2008
89NEBDEVICE, SPARK GAP, ENERGY WAVE FOR PAIN RELIEF
118NOT LISTED
Southwest Import District Office (SWI-DO)
3/3/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
Southwest Import District Office (SWI-DO)
3/3/2008
73CAWGENERATOR, OXYGEN, PORTABLE
118NOT LISTED
Southwest Import District Office (SWI-DO)
3/3/2008
73BYGMASK, OXYGEN
118NOT LISTED
Southwest Import District Office (SWI-DO)
3/3/2008
89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING
118NOT LISTED
Southwest Import District Office (SWI-DO)
3/3/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Guangzhou Jinyimei's FDA import refusal history?

Guangzhou Jinyimei (FEI: 3005990926) has 50 FDA import refusal record(s) in our database, spanning from 3/3/2008 to 5/26/2008.

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 Jinyimei's FEI number is 3005990926.

What types of violations has Guangzhou Jinyimei received?

Guangzhou Jinyimei 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 Jinyimei come from?

All FDA import refusal data for Guangzhou Jinyimei 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.