ImportRefusal LogoImportRefusal

Xian Zi Beauty Center Inc

⚠️ Moderate Risk

FEI: 3008841850 • Kwai Chung • CHINA

FEI

FEI Number

3008841850

📍

Location

Kwai Chung

🇨🇳

Country

CHINA
🏢

Address

Kwai Tak Street, , Kwai Chung, , 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
5/5/2011
Latest Refusal
5/5/2011
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).

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

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
5/5/2011
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
126FAILS STD
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Xian Zi Beauty Center Inc's FDA import refusal history?

Xian Zi Beauty Center Inc (FEI: 3008841850) has 1 FDA import refusal record(s) in our database, spanning from 5/5/2011 to 5/5/2011.

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. Xian Zi Beauty Center Inc's FEI number is 3008841850.

What types of violations has Xian Zi Beauty Center Inc received?

Xian Zi Beauty Center Inc 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 Xian Zi Beauty Center Inc come from?

All FDA import refusal data for Xian Zi Beauty Center Inc 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.