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VISION RENU TAIWAN CORPORATION

⚠️ Moderate Risk

FEI: 3012794851 • TAIPEI • TAIWAN

FEI

FEI Number

3012794851

📍

Location

TAIPEI

🇹🇼

Country

TAIWAN
🏢

Address

8F, NO. 308, SEC. 1, NE, , TAIPEI, , Taiwan

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/23/2017
Latest Refusal
1/23/2017
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

1181×

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).

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
1/23/2017
86LQJLENS, SURGICAL, LASER, ACCESSORY, OPHTHALMIC LASER
118NOT LISTED
476NO REGISTR
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is VISION RENU TAIWAN CORPORATION's FDA import refusal history?

VISION RENU TAIWAN CORPORATION (FEI: 3012794851) has 1 FDA import refusal record(s) in our database, spanning from 1/23/2017 to 1/23/2017.

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. VISION RENU TAIWAN CORPORATION's FEI number is 3012794851.

What types of violations has VISION RENU TAIWAN CORPORATION received?

VISION RENU TAIWAN CORPORATION 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 VISION RENU TAIWAN CORPORATION come from?

All FDA import refusal data for VISION RENU TAIWAN CORPORATION 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.