ImportRefusal LogoImportRefusal

Hong Jin Zi Xun Fu We Bu

⚠️ Moderate Risk

FEI: 3007068602 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3007068602

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

49 Liwan Road, , Guangzhou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

44.0
LowModerateHighCritical

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

Statistics

20
Total Refusals
2
Unique Violations
2/12/2009
Latest Refusal
12/29/2008
Earliest Refusal

Score Breakdown

Violation Severity
48.2×40%
Refusal Volume
49.0×30%
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

11820×

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).

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

DateProductViolationsDivision
2/12/2009
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)
12/29/2008
89IMBCABINET, MOIST STEAM
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
89IMBCABINET, MOIST STEAM
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
89IMBCABINET, MOIST STEAM
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/29/2008
79GFEBRUSH, DERMABRASION
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Hong Jin Zi Xun Fu We Bu's FDA import refusal history?

Hong Jin Zi Xun Fu We Bu (FEI: 3007068602) has 20 FDA import refusal record(s) in our database, spanning from 12/29/2008 to 2/12/2009.

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. Hong Jin Zi Xun Fu We Bu's FEI number is 3007068602.

What types of violations has Hong Jin Zi Xun Fu We Bu received?

Hong Jin Zi Xun Fu We Bu 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 Hong Jin Zi Xun Fu We Bu come from?

All FDA import refusal data for Hong Jin Zi Xun Fu We Bu 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.