ImportRefusal LogoImportRefusal

Sanwa Kagaku Kenkyusho Co. Ltd

⚠️ Moderate Risk

FEI: 3010847877 • Higashiku, Nagoya • JAPAN

FEI

FEI Number

3010847877

📍

Location

Higashiku, Nagoya

🇯🇵

Country

JAPAN
🏢

Address

35, Higashi-sotobori-cho, , Higashiku, Nagoya, Japan

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/28/2014
Latest Refusal
7/28/2014
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
7/28/2014
61PIA99ANTI-DIABETIC N.E.C.
16DIRECTIONS
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Sanwa Kagaku Kenkyusho Co. Ltd's FDA import refusal history?

Sanwa Kagaku Kenkyusho Co. Ltd (FEI: 3010847877) has 1 FDA import refusal record(s) in our database, spanning from 7/28/2014 to 7/28/2014.

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. Sanwa Kagaku Kenkyusho Co. Ltd's FEI number is 3010847877.

What types of violations has Sanwa Kagaku Kenkyusho Co. Ltd received?

Sanwa Kagaku Kenkyusho 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 Sanwa Kagaku Kenkyusho Co. Ltd come from?

All FDA import refusal data for Sanwa Kagaku Kenkyusho 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.