Wenzhou Tianxin Industry & Trade Co., Ltd
⚠️ Moderate Risk
FEI: 3004504967 • Wenzhou • CHINA
FEI Number
3004504967
Location
Wenzhou
Country
CHINAAddress
No. 23 Exing Road, Ehu Industrial Area,, South Baixiang, Wenzhou, , China
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 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).
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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/21/2013 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | New York District Office (NYK-DO) | |
| 8/21/2013 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | New York District Office (NYK-DO) | |
| 1/13/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | New York District Office (NYK-DO) | |
| 7/25/2011 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | 16DIRECTIONS | Detroit District Office (DET-DO) |
| 3/13/2009 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | New York District Office (NYK-DO) | |
| 6/18/2007 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 278NO TAG | Los Angeles District Office (LOS-DO) |
| 5/21/2007 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | 126FAILS STD | Los Angeles District Office (LOS-DO) |
| 10/4/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 126FAILS STD | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Wenzhou Tianxin Industry & Trade Co., Ltd's FDA import refusal history?
Wenzhou Tianxin Industry & Trade Co., Ltd (FEI: 3004504967) has 8 FDA import refusal record(s) in our database, spanning from 10/4/2005 to 8/21/2013.
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. Wenzhou Tianxin Industry & Trade Co., Ltd's FEI number is 3004504967.
What types of violations has Wenzhou Tianxin Industry & Trade Co., Ltd received?
Wenzhou Tianxin Industry & Trade Co., Ltd has been cited for 4 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 Wenzhou Tianxin Industry & Trade Co., Ltd come from?
All FDA import refusal data for Wenzhou Tianxin Industry & Trade 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.