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Daiichi Pharmaceutical Co.Ltd.

✅ Low Risk

FEI: 3003020454 • Chuo, Tokyo • JAPAN

FEI

FEI Number

3003020454

📍

Location

Chuo, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

3 Chome 10-14, Nipponbashi, Chuo, Tokyo, 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
6/27/2019
Latest Refusal
6/27/2019
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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
6/27/2019
66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
3260NO ENGLISH
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Daiichi Pharmaceutical Co.Ltd.'s FDA import refusal history?

Daiichi Pharmaceutical Co.Ltd. (FEI: 3003020454) has 1 FDA import refusal record(s) in our database, spanning from 6/27/2019 to 6/27/2019.

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. Daiichi Pharmaceutical Co.Ltd.'s FEI number is 3003020454.

What types of violations has Daiichi Pharmaceutical Co.Ltd. received?

Daiichi Pharmaceutical 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 Daiichi Pharmaceutical Co.Ltd. come from?

All FDA import refusal data for Daiichi Pharmaceutical 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.