12f
⚠️ Moderate Risk
FEI: 3010061132 • Shenzhenshenzhen • CHINA
FEI Number
3010061132
Location
Shenzhenshenzhen
Country
CHINAAddress
Shuntian Building No 62, , Shenzhenshenzhen, , 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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/15/2013 | 79FXXMASK, SURGICAL | New York District Office (NYK-DO) | |
| 5/15/2013 | 80KCTSTERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES | New York District Office (NYK-DO) | |
| 5/15/2013 | 80KCTSTERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES | New York District Office (NYK-DO) | |
| 5/15/2013 | 76EFHPAPER, ARTICULATION | New York District Office (NYK-DO) | |
| 5/15/2013 | 80KCTSTERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES | New York District Office (NYK-DO) | |
| 5/15/2013 | 79FXXMASK, SURGICAL | New York District Office (NYK-DO) | |
| 5/15/2013 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is 12f's FDA import refusal history?
12f (FEI: 3010061132) has 7 FDA import refusal record(s) in our database, spanning from 5/15/2013 to 5/15/2013.
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. 12f's FEI number is 3010061132.
What types of violations has 12f received?
12f 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 12f come from?
All FDA import refusal data for 12f 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.