Sun Crown
⚠️ Moderate Risk
FEI: 3008472952 • Fo Tanfo Tan • HONG KONG
FEI Number
3008472952
Location
Fo Tanfo Tan
Country
HONG KONGAddress
Rm G 7/F Blk 1 Kin Ho Ind Bldg14-24 Au, , Fo Tanfo Tan, , 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/29/2011 | 89ILXDIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT | Cincinnati District Office (CIN-DO) | |
| 12/29/2011 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Cincinnati District Office (CIN-DO) | |
| 12/29/2011 | 89IPFSTIMULATOR, MUSCLE, POWERED | Cincinnati District Office (CIN-DO) | |
| 12/29/2011 | 79GFEBRUSH, DERMABRASION | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sun Crown's FDA import refusal history?
Sun Crown (FEI: 3008472952) has 4 FDA import refusal record(s) in our database, spanning from 12/29/2011 to 12/29/2011.
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. Sun Crown's FEI number is 3008472952.
What types of violations has Sun Crown received?
Sun Crown 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 Sun Crown come from?
All FDA import refusal data for Sun Crown 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.