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Oya Laser Limited

⚠️ Moderate Risk

FEI: 3010390541 • Guangdong • CHINA

FEI

FEI Number

3010390541

📍

Location

Guangdong

🇨🇳

Country

CHINA
🏢

Address

3f Building 9 Nangang 2nd, , Guangdong, , China

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
11/15/2013
Latest Refusal
11/15/2013
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

2781×

NO TAG

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

Refusal History

DateProductViolationsDivision
11/15/2013
95REBHIGH-POWER LASER LIGHT SHOW, DISPLAY PRODUCTS
126FAILS STD
278NO TAG
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Oya Laser Limited's FDA import refusal history?

Oya Laser Limited (FEI: 3010390541) has 1 FDA import refusal record(s) in our database, spanning from 11/15/2013 to 11/15/2013.

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. Oya Laser Limited's FEI number is 3010390541.

What types of violations has Oya Laser Limited received?

Oya Laser Limited 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 Oya Laser Limited come from?

All FDA import refusal data for Oya Laser Limited 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.