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Rnu Co., LTD.

✅ Low Risk

FEI: 3013316278 • Dong-gu, Daegugwangyeog-si • SOUTH KOREA

FEI

FEI Number

3013316278

📍

Location

Dong-gu, Daegugwangyeog-si

🇰🇷
🏢

Address

58 Maeyeo-ro, , Dong-gu, Daegugwangyeog-si, South Korea

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/27/2023
Latest Refusal
1/27/2023
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
26.9×20%
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
1/27/2023
80FLGCLEANER, ULTRASONIC, MEDICAL INSTRUMENT
3260NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Rnu Co., LTD.'s FDA import refusal history?

Rnu Co., LTD. (FEI: 3013316278) has 1 FDA import refusal record(s) in our database, spanning from 1/27/2023 to 1/27/2023.

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. Rnu Co., LTD.'s FEI number is 3013316278.

What types of violations has Rnu Co., LTD. received?

Rnu 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 Rnu Co., LTD. come from?

All FDA import refusal data for Rnu 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.