FOSHAN NANHAI NEW FACE BEAUTY INSTRUMENT FACTORY
⚠️ Moderate Risk
FEI: 3007539302 • Foshan • CHINA
FEI Number
3007539302
Location
Foshan
Country
CHINAAddress
SONGJIANG INDUSTRIAL ZONE, HENGJIANG, YANBU, NANHAI, Foshan, , 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 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.
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).
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).
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 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 |
|---|---|---|---|
| 11/23/2011 | 79GFEBRUSH, DERMABRASION | Seattle District Office (SEA-DO) | |
| 11/4/2011 | 79GEDBRUSH, DERMABRASION, MANUAL | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 10/31/2011 | 79GFEBRUSH, DERMABRASION | Seattle District Office (SEA-DO) | |
| 10/31/2011 | 79GFEBRUSH, DERMABRASION | Seattle District Office (SEA-DO) | |
| 10/28/2011 | 79GFEBRUSH, DERMABRASION | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 1/20/2010 | 89LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | Cincinnati District Office (CIN-DO) | |
| 12/28/2009 | 97RALMASSAGER, ULTRASONIC NON-MEDICAL DEVICES | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is FOSHAN NANHAI NEW FACE BEAUTY INSTRUMENT FACTORY's FDA import refusal history?
FOSHAN NANHAI NEW FACE BEAUTY INSTRUMENT FACTORY (FEI: 3007539302) has 7 FDA import refusal record(s) in our database, spanning from 12/28/2009 to 11/23/2011.
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. FOSHAN NANHAI NEW FACE BEAUTY INSTRUMENT FACTORY's FEI number is 3007539302.
What types of violations has FOSHAN NANHAI NEW FACE BEAUTY INSTRUMENT FACTORY received?
FOSHAN NANHAI NEW FACE BEAUTY INSTRUMENT FACTORY 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 FOSHAN NANHAI NEW FACE BEAUTY INSTRUMENT FACTORY come from?
All FDA import refusal data for FOSHAN NANHAI NEW FACE BEAUTY INSTRUMENT FACTORY 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.