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JDA Plastic Rubber Co. Ltd.

⚠️ Moderate Risk

FEI: 3003338735 • Tianjin • CHINA

FEI

FEI Number

3003338735

📍

Location

Tianjin

🇨🇳

Country

CHINA
🏢

Address

17 Haibin 7 Road, Tianjin Tree, Trade Zone, Tianjin, , China

Moderate Risk

FDA Import Risk Assessment

34.2
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
9/14/2011
Latest Refusal
5/10/2002
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
4.3×10%
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

4773×

HOLES

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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
9/14/2011
80LZAGLOVE, PATIENT EXAMINATION, POLY
477HOLES
Los Angeles District Office (LOS-DO)
8/20/2008
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Division of Southeast Imports (DSEI)
1/18/2007
80LZAGLOVE, PATIENT EXAMINATION, POLY
477HOLES
Southwest Import District Office (SWI-DO)
5/10/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is JDA Plastic Rubber Co. Ltd.'s FDA import refusal history?

JDA Plastic Rubber Co. Ltd. (FEI: 3003338735) has 4 FDA import refusal record(s) in our database, spanning from 5/10/2002 to 9/14/2011.

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. JDA Plastic Rubber Co. Ltd.'s FEI number is 3003338735.

What types of violations has JDA Plastic Rubber Co. Ltd. received?

JDA Plastic Rubber 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 JDA Plastic Rubber Co. Ltd. come from?

All FDA import refusal data for JDA Plastic Rubber 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.