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Chengdu Day Night Optech Co., Ltd

⚠️ Moderate Risk

FEI: 3009666807 • Chengdu, Sichuan • CHINA

FEI

FEI Number

3009666807

📍

Location

Chengdu, Sichuan

🇨🇳

Country

CHINA
🏢

Address

Bldg 11th, 8 Ke Xin Road; Pixian, Chengdu, Sichuan, China

Moderate Risk

FDA Import Risk Assessment

42.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/22/2012
Latest Refusal
10/22/2012
Earliest Refusal

Score Breakdown

Violation Severity
95.0×40%
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

1171×

DANGEROUS

The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.

3441×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

Refusal History

DateProductViolationsDivision
10/22/2012
95REXIR LASER ILLUMINATOR ONLY/NIGHT VISION SYSTEM, SAFETY, SECURITY, SURVEILLANCE LASER
117DANGEROUS
344WARNINGS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Chengdu Day Night Optech Co., Ltd's FDA import refusal history?

Chengdu Day Night Optech Co., Ltd (FEI: 3009666807) has 1 FDA import refusal record(s) in our database, spanning from 10/22/2012 to 10/22/2012.

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. Chengdu Day Night Optech Co., Ltd's FEI number is 3009666807.

What types of violations has Chengdu Day Night Optech Co., Ltd received?

Chengdu Day Night Optech Co., Ltd 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 Chengdu Day Night Optech Co., Ltd come from?

All FDA import refusal data for Chengdu Day Night Optech 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.