II-IV PHOTONICS (FABRINET)
⚠️ Moderate Risk
FEI: 3014262938 • Klongnueng Klongluan • THAILAND
FEI Number
3014262938
Location
Klongnueng Klongluan
Country
THAILANDAddress
5/6 Moo 6 Soi Khunpra Phaholyothin, Klongnueng Klongluang, Klongnueng Klongluan, , Thailand
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/6/2023 | 95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER | 476NO REGISTR | Division of Northeast Imports (DNEI) |
| 12/6/2023 | 95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER | 476NO REGISTR | Division of Northeast Imports (DNEI) |
| 12/6/2023 | 95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER | 476NO REGISTR | Division of Northeast Imports (DNEI) |
| 11/6/2023 | 95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER | 47NON STD | Division of Southeast Imports (DSEI) |
| 11/3/2023 | 95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER | 476NO REGISTR | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is II-IV PHOTONICS (FABRINET)'s FDA import refusal history?
II-IV PHOTONICS (FABRINET) (FEI: 3014262938) has 5 FDA import refusal record(s) in our database, spanning from 11/3/2023 to 12/6/2023.
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-IV PHOTONICS (FABRINET)'s FEI number is 3014262938.
What types of violations has II-IV PHOTONICS (FABRINET) received?
II-IV PHOTONICS (FABRINET) 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-IV PHOTONICS (FABRINET) come from?
All FDA import refusal data for II-IV PHOTONICS (FABRINET) 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.