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TAISEI CHEMICAL INDUSTRIES

⚠️ Moderate Risk

FEI: 3014948665 • Osaka, Osaka • JAPAN

FEI

FEI Number

3014948665

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

2 Chome 16-2, Fuminosato; Abeno, Osaka, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
1
Unique Violations
12/17/2018
Latest Refusal
12/17/2018
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

1186×

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
12/17/2018
78NLMLAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
118NOT LISTED
Division of Southeast Imports (DSEI)
12/17/2018
78NLMLAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
118NOT LISTED
Division of Southeast Imports (DSEI)
12/17/2018
78NLMLAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
118NOT LISTED
Division of Southeast Imports (DSEI)
12/17/2018
78NLMLAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
118NOT LISTED
Division of Southeast Imports (DSEI)
12/17/2018
78NLMLAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
118NOT LISTED
Division of Southeast Imports (DSEI)
12/17/2018
78NLMLAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TAISEI CHEMICAL INDUSTRIES's FDA import refusal history?

TAISEI CHEMICAL INDUSTRIES (FEI: 3014948665) has 6 FDA import refusal record(s) in our database, spanning from 12/17/2018 to 12/17/2018.

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. TAISEI CHEMICAL INDUSTRIES's FEI number is 3014948665.

What types of violations has TAISEI CHEMICAL INDUSTRIES received?

TAISEI CHEMICAL INDUSTRIES 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 TAISEI CHEMICAL INDUSTRIES come from?

All FDA import refusal data for TAISEI CHEMICAL INDUSTRIES 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.