Beijing Anchorfree Technology Co., Ltd
⚠️ Moderate Risk
FEI: 3009406433 • Beijing, Beijing • CHINA
FEI Number
3009406433
Location
Beijing, Beijing
Country
CHINAAddress
No. 1 Factory, Lightline, 1st Fl.; Tongzhou, Beijing, Beijing, 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).
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
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 |
|---|---|---|---|
| 6/29/2012 | 79MDDDEVICE, DERMAL REPLACEMENT | Florida District Office (FLA-DO) | |
| 6/5/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 4/26/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Beijing Anchorfree Technology Co., Ltd's FDA import refusal history?
Beijing Anchorfree Technology Co., Ltd (FEI: 3009406433) has 3 FDA import refusal record(s) in our database, spanning from 4/26/2012 to 6/29/2012.
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. Beijing Anchorfree Technology Co., Ltd's FEI number is 3009406433.
What types of violations has Beijing Anchorfree Technology Co., Ltd received?
Beijing Anchorfree Technology 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 Beijing Anchorfree Technology Co., Ltd come from?
All FDA import refusal data for Beijing Anchorfree Technology 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.