Shaanxi Xingmao Industry co., Ltd.
⚠️ Moderate Risk
FEI: 3004027120 • Xi'an Shaanxi • CHINA
FEI Number
3004027120
Location
Xi'an Shaanxi
Country
CHINAAddress
5C, B Bldg., Beilong Sqr., #126,, East Road of Xiaohai, Xi'an Shaanxi, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 1/6/2020 | 86NKYBLADE, KERATOME, REPROCESSED | Division of Southeast Imports (DSEI) | |
| 1/6/2020 | 86HNNKNIFE, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 4/25/2012 | 79GAHSTYLET, SURGICAL, GENERAL & PLASTIC SURGERY | Seattle District Office (SEA-DO) | |
| 4/25/2012 | 79GAHSTYLET, SURGICAL, GENERAL & PLASTIC SURGERY | Seattle District Office (SEA-DO) | |
| 4/25/2012 | 79EMFKNIFE, SURGICAL | Seattle District Office (SEA-DO) | |
| 4/25/2012 | 79EMFKNIFE, SURGICAL | Seattle District Office (SEA-DO) | |
| 4/25/2012 | 79EMFKNIFE, SURGICAL | Seattle District Office (SEA-DO) | |
| 4/25/2012 | 79EMFKNIFE, SURGICAL | Seattle District Office (SEA-DO) | |
| 4/25/2012 | 79EMFKNIFE, SURGICAL | Seattle District Office (SEA-DO) | |
| 4/25/2012 | 79GAHSTYLET, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 4/25/2012 | 79GAHSTYLET, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Shaanxi Xingmao Industry co., Ltd.'s FDA import refusal history?
Shaanxi Xingmao Industry co., Ltd. (FEI: 3004027120) has 11 FDA import refusal record(s) in our database, spanning from 4/25/2012 to 1/6/2020.
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. Shaanxi Xingmao Industry co., Ltd.'s FEI number is 3004027120.
What types of violations has Shaanxi Xingmao Industry co., Ltd. received?
Shaanxi Xingmao Industry co., Ltd. has been cited for 5 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 Shaanxi Xingmao Industry co., Ltd. come from?
All FDA import refusal data for Shaanxi Xingmao Industry 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.