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Nanjiang Ioptron S

✅ Low Risk

FEI: 3007805316 • Nanjing • CHINA

FEI

FEI Number

3007805316

📍

Location

Nanjing

🇨🇳

Country

CHINA
🏢

Address

37 Long Panzhonglu, , Nanjing, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/30/2009
Latest Refusal
10/30/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

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).

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.

Refusal History

DateProductViolationsDivision
10/30/2009
95L22LASER PRODUCT FOR NON-MEDICAL USE
278NO TAG
47NON STD
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Nanjiang Ioptron S's FDA import refusal history?

Nanjiang Ioptron S (FEI: 3007805316) has 1 FDA import refusal record(s) in our database, spanning from 10/30/2009 to 10/30/2009.

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. Nanjiang Ioptron S's FEI number is 3007805316.

What types of violations has Nanjiang Ioptron S received?

Nanjiang Ioptron S 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 Nanjiang Ioptron S come from?

All FDA import refusal data for Nanjiang Ioptron S 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.