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Ispa Inc

Low Risk

FEI: 3007640340 • Tokyotokyo • JAPAN

FEI

FEI Number

3007640340

📍

Location

Tokyotokyo

🇯🇵

Country

JAPAN
🏢

Address

7-1-16 110f Akasakaminaoto-Ku, , Tokyotokyo, , 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
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
3260NO ENGLISH
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Ispa Inc's FDA import refusal history?

Ispa Inc (FEI: 3007640340) 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. Ispa Inc's FEI number is 3007640340.

What types of violations has Ispa Inc received?

Ispa Inc 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 Ispa Inc come from?

All FDA import refusal data for Ispa Inc 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.