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DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD

✅ Low Risk

FEI: 3008955719 • Danyang, Jiangsu • CHINA

FEI

FEI Number

3008955719

📍

Location

Danyang, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Eyeglasses Industrial Park, Danfu Road, Danyang, Jiangsu, China

Low Risk

FDA Import Risk Assessment

17.5
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
1
Unique Violations
4/20/2020
Latest Refusal
12/21/2011
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
2.4×10%
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

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
4/20/2020
89IMDPACK, HOT OR COLD, DISPOSABLE
341REGISTERED
Division of Northern Border Imports (DNBI)
12/21/2011
89IMDPACK, HOT OR COLD, DISPOSABLE
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD's FDA import refusal history?

DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD (FEI: 3008955719) has 2 FDA import refusal record(s) in our database, spanning from 12/21/2011 to 4/20/2020.

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. DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD's FEI number is 3008955719.

What types of violations has DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD received?

DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS 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 DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD come from?

All FDA import refusal data for DANYANG RAPID AID HOT AND COLD THERAPY 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.