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PIERAS CO LTD

✅ Low Risk

FEI: 3013496473 • Osaka, Osaka • JAPAN

FEI

FEI Number

3013496473

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

Osada 1-30, Honmachibashi; Chuo; Honmachibashi; Chuo, Osaka, Osaka, Japan

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
6/27/2019
Latest Refusal
6/27/2019
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

32603×

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)
6/27/2019
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
3260NO ENGLISH
Division of West Coast Imports (DWCI)
6/27/2019
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
3260NO ENGLISH
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is PIERAS CO LTD's FDA import refusal history?

PIERAS CO LTD (FEI: 3013496473) has 3 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. PIERAS CO LTD's FEI number is 3013496473.

What types of violations has PIERAS CO LTD received?

PIERAS 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 PIERAS CO LTD come from?

All FDA import refusal data for PIERAS 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.