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RF CO LTD (RF SYSTEM LAB)

⚠️ Moderate Risk

FEI: 3022345059 • Nagano City • JAPAN

FEI

FEI Number

3022345059

📍

Location

Nagano City

🇯🇵

Country

JAPAN
🏢

Address

299-16 Minani Nagaike, , Nagano City, , Japan

Moderate Risk

FDA Import Risk Assessment

37.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/4/2024
Latest Refusal
6/4/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
67.5×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
6/4/2024
76QJKINTRAORAL CAMERA
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is RF CO LTD (RF SYSTEM LAB)'s FDA import refusal history?

RF CO LTD (RF SYSTEM LAB) (FEI: 3022345059) has 1 FDA import refusal record(s) in our database, spanning from 6/4/2024 to 6/4/2024.

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. RF CO LTD (RF SYSTEM LAB)'s FEI number is 3022345059.

What types of violations has RF CO LTD (RF SYSTEM LAB) received?

RF CO LTD (RF SYSTEM LAB) 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 RF CO LTD (RF SYSTEM LAB) come from?

All FDA import refusal data for RF CO LTD (RF SYSTEM LAB) 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.