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SAISHINKAN PHARMACEUTICAL CO

✅ Low Risk

FEI: 3016860724 • Kamimashiki-Gun, Kumamoto • JAPAN

FEI

FEI Number

3016860724

📍

Location

Kamimashiki-Gun, Kumamoto

🇯🇵

Country

JAPAN
🏢

Address

1363-1, Oazajichu; Mashiki-Machi, Kamimashiki-Gun, Kumamoto, Japan

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/14/2020
Latest Refusal
8/14/2020
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
8/14/2020
66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
472NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SAISHINKAN PHARMACEUTICAL CO's FDA import refusal history?

SAISHINKAN PHARMACEUTICAL CO (FEI: 3016860724) has 1 FDA import refusal record(s) in our database, spanning from 8/14/2020 to 8/14/2020.

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. SAISHINKAN PHARMACEUTICAL CO's FEI number is 3016860724.

What types of violations has SAISHINKAN PHARMACEUTICAL CO received?

SAISHINKAN PHARMACEUTICAL CO 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 SAISHINKAN PHARMACEUTICAL CO come from?

All FDA import refusal data for SAISHINKAN PHARMACEUTICAL CO 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.