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CHANGZHOU XIETONG INDUSTRIES CO LTD

⚠️ Moderate Risk

FEI: 3012697315 • Changzhou, Jiangsu • CHINA

FEI

FEI Number

3012697315

📍

Location

Changzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Room 1105, Gelin No. 107 Mishihe Road, Changzhou, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/15/2014
Latest Refusal
9/15/2014
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

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).

Refusal History

DateProductViolationsDivision
9/15/2014
87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
237NO PMA
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is CHANGZHOU XIETONG INDUSTRIES CO LTD's FDA import refusal history?

CHANGZHOU XIETONG INDUSTRIES CO LTD (FEI: 3012697315) has 1 FDA import refusal record(s) in our database, spanning from 9/15/2014 to 9/15/2014.

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. CHANGZHOU XIETONG INDUSTRIES CO LTD's FEI number is 3012697315.

What types of violations has CHANGZHOU XIETONG INDUSTRIES CO LTD received?

CHANGZHOU XIETONG INDUSTRIES CO LTD has been cited for 1 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 CHANGZHOU XIETONG INDUSTRIES CO LTD come from?

All FDA import refusal data for CHANGZHOU XIETONG INDUSTRIES 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.