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NICHI IKO PHARMACEUTICAL CO LTD

⚠️ Moderate Risk

FEI: 3015880421 • Chuo, Tokyo • JAPAN

FEI

FEI Number

3015880421

📍

Location

Chuo, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 5-4, Nihonbashihon-Cho, Chuo, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/17/2020
Latest Refusal
7/17/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
7/17/2020
62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NICHI IKO PHARMACEUTICAL CO LTD's FDA import refusal history?

NICHI IKO PHARMACEUTICAL CO LTD (FEI: 3015880421) has 1 FDA import refusal record(s) in our database, spanning from 7/17/2020 to 7/17/2020.

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. NICHI IKO PHARMACEUTICAL CO LTD's FEI number is 3015880421.

What types of violations has NICHI IKO PHARMACEUTICAL CO LTD received?

NICHI IKO 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 NICHI IKO PHARMACEUTICAL CO LTD come from?

All FDA import refusal data for NICHI IKO 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.