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O/B Royalking Industrial Corp

✅ Low Risk

FEI: 3005809066 • Taipei • TAIWAN

FEI

FEI Number

3005809066

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

7 Fl., No.467,Chung Hsiao East Rd, , Taipei, , Taiwan

Low Risk

FDA Import Risk Assessment

23.4
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/17/2017
Latest Refusal
12/27/2001
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
1.3×10%
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

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

3411×

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).

Refusal History

DateProductViolationsDivision
7/17/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Northern Border Imports (DNBI)
12/27/2001
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is O/B Royalking Industrial Corp's FDA import refusal history?

O/B Royalking Industrial Corp (FEI: 3005809066) has 2 FDA import refusal record(s) in our database, spanning from 12/27/2001 to 7/17/2017.

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. O/B Royalking Industrial Corp's FEI number is 3005809066.

What types of violations has O/B Royalking Industrial Corp received?

O/B Royalking Industrial Corp 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 O/B Royalking Industrial Corp come from?

All FDA import refusal data for O/B Royalking Industrial Corp 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.