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Rongyao Plastic Produce Co., Ltd

⚠️ Moderate Risk

FEI: 3009130592 • Hengshui • CHINA

FEI

FEI Number

3009130592

📍

Location

Hengshui

🇨🇳

Country

CHINA
🏢

Address

#58 Binhu, , Hengshui, , China

Moderate Risk

FDA Import Risk Assessment

33.4
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
1/16/2019
Latest Refusal
6/4/2014
Earliest Refusal

Score Breakdown

Violation Severity
62.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
8.7×10%
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

4774×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

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
1/16/2019
80LYZGLOVE, PATIENT EXAMINATION, VINYL
341REGISTERED
477HOLES
Division of Southeast Imports (DSEI)
7/29/2014
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Southwest Import District Office (SWI-DO)
6/4/2014
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Baltimore District Office (BLT-DO)
6/4/2014
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Rongyao Plastic Produce Co., Ltd's FDA import refusal history?

Rongyao Plastic Produce Co., Ltd (FEI: 3009130592) has 4 FDA import refusal record(s) in our database, spanning from 6/4/2014 to 1/16/2019.

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. Rongyao Plastic Produce Co., Ltd's FEI number is 3009130592.

What types of violations has Rongyao Plastic Produce Co., Ltd received?

Rongyao Plastic Produce Co., Ltd 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 Rongyao Plastic Produce Co., Ltd come from?

All FDA import refusal data for Rongyao Plastic Produce 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.