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Zhangjiagang Rechle Plastics Rubber Products Co Ltd

✅ Low Risk

FEI: 3007134643 • Zhangjiagang • CHINA

FEI

FEI Number

3007134643

📍

Location

Zhangjiagang

🇨🇳

Country

CHINA
🏢

Address

Fengtian Road Fenghuang, , Zhangjiagang, , China

Low Risk

FDA Import Risk Assessment

23.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
7/15/2009
Latest Refusal
7/15/2009
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
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

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

4771×

HOLES

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

4841×

DV NAME

The article appears to be a device and its labeling fails to bear the proprietary or established name.

Refusal History

DateProductViolationsDivision
7/15/2009
80LZAGLOVE, PATIENT EXAMINATION, POLY
333LACKS FIRM
477HOLES
484DV NAME
New England District Office (NWE-DO)

Frequently Asked Questions

What is Zhangjiagang Rechle Plastics Rubber Products Co Ltd's FDA import refusal history?

Zhangjiagang Rechle Plastics Rubber Products Co Ltd (FEI: 3007134643) has 1 FDA import refusal record(s) in our database, spanning from 7/15/2009 to 7/15/2009.

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. Zhangjiagang Rechle Plastics Rubber Products Co Ltd's FEI number is 3007134643.

What types of violations has Zhangjiagang Rechle Plastics Rubber Products Co Ltd received?

Zhangjiagang Rechle Plastics Rubber Products Co Ltd 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 Zhangjiagang Rechle Plastics Rubber Products Co Ltd come from?

All FDA import refusal data for Zhangjiagang Rechle Plastics Rubber 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.