Transverse Industries Co., Ltd.
⚠️ Moderate Risk
FEI: 1000284205 • New Taipei City • TAIWAN
FEI Number
1000284205
Location
New Taipei City
Country
TAIWANAddress
Hsin Chuang City, No. 305 Huacheng Rd.; Xinzhuang Dist., New Taipei City, , Taiwan
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
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.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2009 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | Southwest Import District Office (SWI-DO) |
| 5/6/2009 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | Southwest Import District Office (SWI-DO) |
| 5/6/2009 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | Southwest Import District Office (SWI-DO) |
| 4/30/2009 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Los Angeles District Office (LOS-DO) |
| 1/9/2008 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 9/29/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Detroit District Office (DET-DO) |
| 9/29/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Detroit District Office (DET-DO) |
| 9/29/2005 | 79MXGLAMP, UVC (FOR TREATING SKIN AND WOUNDS) | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Transverse Industries Co., Ltd.'s FDA import refusal history?
Transverse Industries Co., Ltd. (FEI: 1000284205) has 8 FDA import refusal record(s) in our database, spanning from 9/29/2005 to 5/6/2009.
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. Transverse Industries Co., Ltd.'s FEI number is 1000284205.
What types of violations has Transverse Industries Co., Ltd. received?
Transverse Industries Co., Ltd. has been cited for 3 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 Transverse Industries Co., Ltd. come from?
All FDA import refusal data for Transverse Industries 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.