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Ret Inc

✅ Low Risk

FEI: 3007560076 • Chungbuk • SOUTH KOREA

FEI

FEI Number

3007560076

📍

Location

Chungbuk

🇰🇷
🏢

Address

5f Ohchangventure 641-1 Kakri Oh, , Chungbuk, , South Korea

Low Risk

FDA Import Risk Assessment

21.4
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
2/11/2011
Latest Refusal
12/1/2009
Earliest Refusal

Score Breakdown

Violation Severity
36.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
16.7×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
2/11/2011
86KYBLENS, GUIDE, INTRAOCULAR
118NOT LISTED
341REGISTERED
Seattle District Office (SEA-DO)
12/1/2009
86MSSFOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
118NOT LISTED
333LACKS FIRM
341REGISTERED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Ret Inc's FDA import refusal history?

Ret Inc (FEI: 3007560076) has 2 FDA import refusal record(s) in our database, spanning from 12/1/2009 to 2/11/2011.

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. Ret Inc's FEI number is 3007560076.

What types of violations has Ret Inc received?

Ret Inc has been cited for 3 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 Ret Inc come from?

All FDA import refusal data for Ret 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.