Junguan Beauty Co Ltd Street
✅ Low Risk
FEI: 3009182128 • Hong Knoghong Knog • HONG KONG
FEI Number
3009182128
Location
Hong Knoghong Knog
Country
HONG KONGAddress
Rm 706, Yile Commercial Building,, , Hong Knoghong Knog, , Hong Kong
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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.
Refusal History
Frequently Asked Questions
What is Junguan Beauty Co Ltd Street's FDA import refusal history?
Junguan Beauty Co Ltd Street (FEI: 3009182128) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2011 to 10/28/2011.
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. Junguan Beauty Co Ltd Street's FEI number is 3009182128.
What types of violations has Junguan Beauty Co Ltd Street received?
Junguan Beauty Co Ltd Street has been cited for 3 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 Junguan Beauty Co Ltd Street come from?
All FDA import refusal data for Junguan Beauty Co Ltd Street 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.