Foshan Nanhai Newface Beauty Instruments
⚠️ Moderate Risk
FEI: 3009717767 • Kowloon Bay, Kwun Tong • HONG KONG
FEI Number
3009717767
Location
Kowloon Bay, Kwun Tong
Country
HONG KONGAddress
G/F, Fat Lee Ind Bldg; Tai Road, Kowloon Bay, Kwun Tong, Hong Kong
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 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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/1/2012 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Cincinnati District Office (CIN-DO) | |
| 10/2/2012 | 79GEDBRUSH, DERMABRASION, MANUAL | Cincinnati District Office (CIN-DO) | |
| 9/25/2012 | 89LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | Cincinnati District Office (CIN-DO) | |
| 9/25/2012 | 90LMCCAMERA, MULTI FORMAT, RADIOLOGICAL | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Foshan Nanhai Newface Beauty Instruments's FDA import refusal history?
Foshan Nanhai Newface Beauty Instruments (FEI: 3009717767) has 4 FDA import refusal record(s) in our database, spanning from 9/25/2012 to 11/1/2012.
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. Foshan Nanhai Newface Beauty Instruments's FEI number is 3009717767.
What types of violations has Foshan Nanhai Newface Beauty Instruments received?
Foshan Nanhai Newface Beauty Instruments 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 Newface Beauty Instruments come from?
All FDA import refusal data for Foshan Nanhai Newface Beauty Instruments 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.