Zhongshan City Feihong Metal Products Co.,Ltd.
⚠️ Moderate Risk
FEI: 3004163428 • Zhongshan City • CHINA
FEI Number
3004163428
Location
Zhongshan City
Country
CHINAAddress
1st Zhongshan Road, , Zhongshan City, , 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/27/2008 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 11/19/2007 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 11/19/2007 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 126FAILS STD | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Zhongshan City Feihong Metal Products Co.,Ltd.'s FDA import refusal history?
Zhongshan City Feihong Metal Products Co.,Ltd. (FEI: 3004163428) has 4 FDA import refusal record(s) in our database, spanning from 10/15/2005 to 3/27/2008.
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. Zhongshan City Feihong Metal Products Co.,Ltd.'s FEI number is 3004163428.
What types of violations has Zhongshan City Feihong Metal Products Co.,Ltd. received?
Zhongshan City Feihong Metal Products 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 Zhongshan City Feihong Metal Products Co.,Ltd. come from?
All FDA import refusal data for Zhongshan City Feihong Metal Products 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.