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JINHUA IVY HOME TEXTILE CO LTD

✅ Low Risk

FEI: 3013035949 • Jinhua • CHINA

FEI

FEI Number

3013035949

📍

Location

Jinhua

🇨🇳

Country

CHINA
🏢

Address

Rm A, 518 Shuanglon, Jinhua, , China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/16/2018
Latest Refusal
7/16/2018
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
7/16/2018
85NUQPAD, MENSTRUAL, REUSABLE
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is JINHUA IVY HOME TEXTILE CO LTD's FDA import refusal history?

JINHUA IVY HOME TEXTILE CO LTD (FEI: 3013035949) has 1 FDA import refusal record(s) in our database, spanning from 7/16/2018 to 7/16/2018.

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. JINHUA IVY HOME TEXTILE CO LTD's FEI number is 3013035949.

What types of violations has JINHUA IVY HOME TEXTILE CO LTD received?

JINHUA IVY HOME TEXTILE 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 JINHUA IVY HOME TEXTILE CO LTD come from?

All FDA import refusal data for JINHUA IVY HOME TEXTILE 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.