Sfc Service Ltd
⚠️ Moderate Risk
FEI: 3009793006 • Baoan District • CHINA
FEI Number
3009793006
Location
Baoan District
Country
CHINAAddress
1 F Of Building E.Wen Tao Indust, , Baoan District, , 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.
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.
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.
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2013 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/15/2012 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 11/15/2012 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | New Orleans District Office (NOL-DO) | |
| 11/15/2012 | 89IMIDIATHERMY, ULTRASONIC, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | New Orleans District Office (NOL-DO) | |
| 11/15/2012 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sfc Service Ltd's FDA import refusal history?
Sfc Service Ltd (FEI: 3009793006) has 5 FDA import refusal record(s) in our database, spanning from 11/15/2012 to 1/31/2013.
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. Sfc Service Ltd's FEI number is 3009793006.
What types of violations has Sfc Service Ltd received?
Sfc Service Ltd has been cited for 6 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 Sfc Service Ltd come from?
All FDA import refusal data for Sfc Service 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.