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Calm International

✅ Low Risk

FEI: 3011278887 • *shizuoka*shizuoka • JAPAN

FEI

FEI Number

3011278887

📍

Location

*shizuoka*shizuoka

🇯🇵

Country

JAPAN
🏢

Address

2419-1 Kando Yoshida-Cho Haibara-Gunb102, , *shizuoka*shizuoka, , Japan

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/10/2015
Latest Refusal
2/10/2015
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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.

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
2/10/2015
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
16DIRECTIONS
3260NO ENGLISH
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Calm International's FDA import refusal history?

Calm International (FEI: 3011278887) has 1 FDA import refusal record(s) in our database, spanning from 2/10/2015 to 2/10/2015.

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. Calm International's FEI number is 3011278887.

What types of violations has Calm International received?

Calm International has been cited for 2 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 Calm International come from?

All FDA import refusal data for Calm International 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.