ImportRefusal LogoImportRefusal

II-VI PHOTONICS

⚠️ Moderate Risk

FEI: 3025907003 • Patumthanee • THAILAND

FEI

FEI Number

3025907003

📍

Location

Patumthanee

🇹🇭

Country

THAILAND
🏢

Address

5/6 Moo 6, Soi Khunpra,5850, Klongnueng, Klongluang, Patumthanee, , Thailand

Moderate Risk

FDA Import Risk Assessment

44.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
12/18/2023
Latest Refusal
12/18/2023
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
22.3×30%
Recency
43.6×20%
Frequency
30.0×10%
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

473×

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.

4763×

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
12/18/2023
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
476NO REGISTR
Division of West Coast Imports (DWCI)
12/18/2023
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
476NO REGISTR
Division of West Coast Imports (DWCI)
12/18/2023
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
476NO REGISTR
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is II-VI PHOTONICS's FDA import refusal history?

II-VI PHOTONICS (FEI: 3025907003) has 3 FDA import refusal record(s) in our database, spanning from 12/18/2023 to 12/18/2023.

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. II-VI PHOTONICS's FEI number is 3025907003.

What types of violations has II-VI PHOTONICS received?

II-VI PHOTONICS 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 II-VI PHOTONICS come from?

All FDA import refusal data for II-VI PHOTONICS 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.