Hongkong Phenitech Co. Limited
⚠️ Moderate Risk
FEI: 3007858905 • Guangdongguangdong • CHINA
FEI Number
3007858905
Location
Guangdongguangdong
Country
CHINAAddress
Building 4, Th; Cuifeng Gardenbuji Area, Guangdongguangdong, , 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
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).
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 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.
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2012 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Cincinnati District Office (CIN-DO) | |
| 12/20/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Cincinnati District Office (CIN-DO) | |
| 12/20/2012 | 89IPFSTIMULATOR, MUSCLE, POWERED | Cincinnati District Office (CIN-DO) | |
| 12/20/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Cincinnati District Office (CIN-DO) | |
| 3/7/2011 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 2380NO PMA/PDP | Los Angeles District Office (LOS-DO) |
| 3/7/2011 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hongkong Phenitech Co. Limited's FDA import refusal history?
Hongkong Phenitech Co. Limited (FEI: 3007858905) has 6 FDA import refusal record(s) in our database, spanning from 3/7/2011 to 12/20/2012.
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. Hongkong Phenitech Co. Limited's FEI number is 3007858905.
What types of violations has Hongkong Phenitech Co. Limited received?
Hongkong Phenitech Co. Limited 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 Hongkong Phenitech Co. Limited come from?
All FDA import refusal data for Hongkong Phenitech Co. Limited 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.