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CHANGCHUN SUNDAY OPTICS CO LTD

⚠️ Moderate Risk

FEI: 3037730936 • Changchun, Jilin • CHINA

FEI

FEI Number

3037730936

📍

Location

Changchun, Jilin

🇨🇳

Country

CHINA
🏢

Address

No 9576 Donghuan Road, Erdao District, Changchun, Jilin, China

Moderate Risk

FDA Import Risk Assessment

47.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/3/2025
Latest Refusal
6/3/2025
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
Recency
87.7×20%
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

471×

NON STD

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 offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

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
6/3/2025
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
47NON STD
476NO REGISTR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CHANGCHUN SUNDAY OPTICS CO LTD's FDA import refusal history?

CHANGCHUN SUNDAY OPTICS CO LTD (FEI: 3037730936) has 1 FDA import refusal record(s) in our database, spanning from 6/3/2025 to 6/3/2025.

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. CHANGCHUN SUNDAY OPTICS CO LTD's FEI number is 3037730936.

What types of violations has CHANGCHUN SUNDAY OPTICS CO LTD received?

CHANGCHUN SUNDAY OPTICS 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 CHANGCHUN SUNDAY OPTICS CO LTD come from?

All FDA import refusal data for CHANGCHUN SUNDAY OPTICS 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.